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PeriOperative ISchemic Evaluation-3 Trial (POISE-3)

Primary Purpose

Perioperative Bleeding, Venous Thrombosis, Arterial Thrombosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tranexamic Acid
Placebo (Saline)
Perioperative hypotension-avoidance strategy
Perioperative hypertension-avoidance strategy
Sponsored by
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perioperative Bleeding focused on measuring Noncardiac surgery, Myocardial injury, Perioperative myocardial infarction, Tranexamic Acid, Hypotension, Hypertension

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  1. Undergoing noncardiac surgery;
  2. ≥ 45 years of age;
  3. Expected to require at least an overnight hospital admission after surgery;
  4. Provide written informed consent to participate in the POISE-3 Trial, AND
  5. Fulfill ≥1 of the following 6 criteria (A-F):

A. NT-proBNP ≥200 ng/L B. History of coronary artery disease C. History of peripheral arterial disease D. History of stroke E. Undergoing major vascular surgery; OR F. Any 3 of 9 risk criteria i. Undergoing major surgery; ii. History of congestive heart failure; iii. History of a transient ischemic attack; iv. Diabetes and currently taking an oral hypoglycemic agent or insulin; v. Age >70 years; vi. History of hypertension; vii. Serum creatinine > 175 µmol/L (> 2.0 mg/dl); viii. History of smoking within 2 years of surgery; ix. Undergoing emergent/urgent surgery.

Exclusion criteria:

  1. Patients undergoing cardiac surgery
  2. Patients undergoing cranial neurosurgery
  3. Planned use of systemic TXA during surgery
  4. Low-risk surgical procedure (based on individual physician's judgment)
  5. Hypersensitivity or known allergy to TXA
  6. Creatinine clearance <30 mL/min (Cockcroft-Gault equation) or on chronic dialysis
  7. History of seizure disorder
  8. Patients with recent stroke, myocardial infarction, acute arterial thrombosis or venous thromboembolism (<3 month)
  9. Patients with fibrinolytic conditions following consumption coagulopathy
  10. Patients with subarachnoid hemorrhage within the past 30 days
  11. Women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding
  12. Previously enrolled in POISE-3 Trial

Sites / Locations

  • Yale New Haven Hospital
  • Cleveland Clinic, Florida
  • Columbia University
  • University of North Carolina at Chapel Hill
  • Wake Forest
  • Cleveland Clinic - Fairview
  • Cleveland Clinic - Main Campus
  • The Ohio State University Wexner Medical Center
  • Cleveland Clinic - Hillcrest
  • Oregon Health & Science University
  • Rhode Island Hospital
  • MD Anderson Cancer Center
  • Queen Elizabeth II Jubilee Hospital
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Flinders Medical Centre
  • Royal Hobart Hospital
  • Eastern Health (Box Hill Hospital)
  • Dandenong Hospital
  • Austin Hospital
  • Royal Melbourne Hospital
  • Fiona Stanley Hospital
  • Western Health
  • Peter MacCallum Hospital
  • John Hunter Hospital
  • Royal Perth
  • Princes of Wales Hospital
  • Goulburn Valley Health
  • Westmead Hospital
  • Medical University of Vienna
  • CHU Brugmann
  • Cliniques Universitaires Saint-Luc
  • Hospital do Coracao de Pocos de Caldas
  • Hospital de Clinicas de Porto Alegre
  • University of Calgary, O'Brien Institute for Public Health
  • University of Alberta
  • Health Sciences Centre
  • Hamilton General Hospital
  • St. Joseph's Healthcare Hamilton
  • Juravinski Hospital & Cancer Centre
  • Kingston Health Sciences Centre
  • University Health Network (Toronto General Hospital)
  • CHUM
  • Sherbrooke
  • Royal University Hospital (Saskatoon)
  • Victoria Hospital
  • Clinica Santa Maria
  • Hospital Hernan Henriquez
  • Second Hospital of Anhui Medical University
  • Shenzhen People's Hospital
  • The Fourth Affiliated Hospital of Harbin Medical University
  • West China Hospital of Sichuan University
  • Bispebjerg Hospital
  • Rigshospitalet, Abdominal Centre
  • Zealand University Hospital
  • Groupe Hospitalier Paris Saint Joseph
  • University Hospital RWTH Aachen
  • University Hospital Bonn
  • Klinikum Dortmund gGmbH
  • University Hospital Düsseldorf
  • Prince of Wales Hospital
  • Surat Institute of Digestive Science
  • Sumandeep Vidyapeeth & Dhiraj General Hospital
  • Nanjappa Hospital
  • Government Medical College
  • Rahate Surgical Hospital
  • Sengupta Hospital & Research Institute
  • AMAI Charitable Trust's Ace Hospital
  • Sidhu Hospital Pvt. Ltd.
  • Christian Medical College, Ludhiana
  • Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow
  • NH Rabindranath Tagore International Inst. of Cardiac Sciences
  • TD Medical College
  • Bangalore Baptist Hospital
  • Ospedale Galliera di Genova
  • IRCCS Galeazzi Orthopedic Institute
  • Instituto Clinico San Siro
  • IRCCS San Raffaele Scientific Institute
  • Port Dickson Hospital
  • Sarawak General Hospital
  • Hospital Kuala Lumpur
  • University Malaya Medical Centre
  • Hospital Pulau Pinang
  • Sungai Buloh Hospital
  • Deventer Ziekenhuis
  • Erasmus University Medical Center
  • Auckland General Hospital
  • Middlemore Hospital
  • Waikato District Health Board
  • Shifa International Hospitals
  • Aga Khan University
  • Jagiellonian University Medical College
  • Specialistyczny Szpital im. E. Szczeklika w Tarnowie
  • Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Górze
  • City Hospital 1 of Arkhangelsk
  • V. Negovskiy Reanimatology Research Institute
  • Moscow Regional Research & Clinical Institute (MONIKI)
  • City Hospital N25
  • E. Meshalkin National Medical Research Center
  • Hospital of Saint-Petersburg State University
  • Tyumen State Medical University
  • Groote Schuur Hospital
  • Sefako Makgatho Health Sciences University (SMU)
  • Steve Biko Academic Hospital - University of Pretoria
  • Hospital Clinic - Barcelona
  • Hospital de la Sta Creu i Sant Pau
  • Hospital Vall D'Hebron
  • Hospital Dr. Josep Trueta
  • Hospital Ramon y Cajal
  • Hospital Universitario Fundacion Alcorcon
  • Hospital Clínico Universitario in Valladolid
  • Medway NHS Foundation Trust
  • Chelsea & Westminster Hospital
  • West Middlesex Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Tranexamic Acid (TXA)

Placebo (0.9% normal saline)

Hypotension-avoidance strategy

Perioperative hypertension-avoidance strategy

Arm Description

Patients will receive a 1g loading dose of intravenous TXA before surgery and a 1g loading dose of intravenous TXA at the end of surgery (wound closure).

Patients will receive a 1g loading dose of placebo (0.9% normal saline) before surgery and a 1g loading dose of placebo (0.9% normal saline) at the end of surgery (wound closure).

Aims to avoid hypotension before surgery (preoperative), during surgery (intraoperative) and for the first 2 days after the day of surgery (postoperative).

Aims to avoid hypertension before surgery (preoperative), during surgery (intraoperative) and for the first 2 days after the day of surgery (postoperative).

Outcomes

Primary Outcome Measures

A composite of life-threatening bleeding, major bleeding, and critical organ bleeding
Number of patients who have at least one of the following: life-threatening bleeding, major bleeding, and critical organ bleeding
A composite of MINS, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism.
Number of patients who have at least one of the following: myocardial injury after noncardiac surgery, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism.
For patients in the blood pressure management arm: A composite of vascular death, non-fatal MINS, non-fatal stroke, and non-fatal cardiac arrest.
Number of patients enrolled in the blood pressure management arm who have at least one of the following: vascular death, non-fatal myocardial injury after noncardiac surgery, non-fatal stroke, and non-fatal cardiac arrest.

Secondary Outcome Measures

A net risk-benefit outcome as a composite of vascular death, and non-fatal life-threatening,major or critical organ bleeding,MINS,stroke,peripheral arterial thrombosis,and symptomatic proximal venous thromboembolism
Number of patients who have at least one of the following: vascular death, and non-fatal life-threatening, major or critical organ bleeding, myocardial injury after noncardiac surgery, stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism,
BIMS
Number of patients who experience bleeding independently associated with mortality after noncardiac surgery (BIMS)
MINS
Number of patients who experience a myocardial injury after noncardiac surgery (MINS)
MINS not fulfilling the universal definition of myocardial infarction
Number of patients who experience a myocardial injury after noncardiac surgery (MINS) not fulfilling the 3rd universal definition of myocardial infarction
Myocardial infarction
Number of patients who experience a myocardial infarction
For patients in the blood pressure management arm: all-cause mortality
Number of patients who die of any cause
For patients in the blood pressure management arm: MINS
Number of patients who experience a myocardial injury after noncardiac surgery (MINS)
For patients in the blood pressure management arm: Myocardial infarction
Number of patients who experience a myocardial infarction
For patients in the blood pressure management arm: MINS not fulfilling the universal definition of myocardial infarction
Number of patients who experience MINS not fulfilling the universal definition of myocardial infarction

Full Information

First Posted
March 16, 2018
Last Updated
August 18, 2023
Sponsor
Population Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03505723
Brief Title
PeriOperative ISchemic Evaluation-3 Trial
Acronym
POISE-3
Official Title
PeriOperative ISchemic Evaluation-3 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 27, 2018 (Actual)
Primary Completion Date
November 8, 2021 (Actual)
Study Completion Date
February 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Population Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a multicentre, international, randomized controlled trial of tranexamic acid (TXA) versus placebo and, using a partial factorial design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy.
Detailed Description
The POISE-3 study is a 10,000 patient, multicentre, international, non-inferiority randomized controlled trial of tranexamic acid (TXA) versus placebo and, using a partial factorial design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy. The primary objective of the study is to determine; if TXA is superior to placebo for the occurrence of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic event; and to determine the impact of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of vascular death and major vascular events in patients who are followed for 30 days after noncardiac surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative Bleeding, Venous Thrombosis, Arterial Thrombosis
Keywords
Noncardiac surgery, Myocardial injury, Perioperative myocardial infarction, Tranexamic Acid, Hypotension, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9535 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic Acid (TXA)
Arm Type
Active Comparator
Arm Description
Patients will receive a 1g loading dose of intravenous TXA before surgery and a 1g loading dose of intravenous TXA at the end of surgery (wound closure).
Arm Title
Placebo (0.9% normal saline)
Arm Type
Placebo Comparator
Arm Description
Patients will receive a 1g loading dose of placebo (0.9% normal saline) before surgery and a 1g loading dose of placebo (0.9% normal saline) at the end of surgery (wound closure).
Arm Title
Hypotension-avoidance strategy
Arm Type
Active Comparator
Arm Description
Aims to avoid hypotension before surgery (preoperative), during surgery (intraoperative) and for the first 2 days after the day of surgery (postoperative).
Arm Title
Perioperative hypertension-avoidance strategy
Arm Type
Placebo Comparator
Arm Description
Aims to avoid hypertension before surgery (preoperative), during surgery (intraoperative) and for the first 2 days after the day of surgery (postoperative).
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
TXA
Intervention Description
Within 20 minutes preceding the anticipated skin incision, patients will receive intravenous TXA at a loading dose of 1g over 10 minutes, with a second 1g bolus given at the end of surgery when closing the wound.
Intervention Type
Drug
Intervention Name(s)
Placebo (Saline)
Other Intervention Name(s)
saline
Intervention Description
Within 20 minutes preceding the anticipated skin incision, patients will receive intravenous placebo (0.9% normal saline) at a loading dose of 1g over 10 minutes, with a second 1g bolus given at the end of surgery when closing the wound.
Intervention Type
Other
Intervention Name(s)
Perioperative hypotension-avoidance strategy
Intervention Description
Perioperative hypotension-avoidance strategy includes: Preoperative algorithm that only continues some antihypertensive medications in a stepwise manner for systolic BP ≥130 mm Hg before surgery, Intraoperative blood pressure targeting a mean arterial pressure (MAP) ≥80 mm Hg Postoperative algorithm that only continues some antihypertensive medications in a stepwise manner for systolic BP ≥130 mm Hg during the first 48 hours after surgery.
Intervention Type
Other
Intervention Name(s)
Perioperative hypertension-avoidance strategy
Intervention Description
Perioperative hypertension-avoidance strategy (i.e., routine care) continues all antihypertensive drugs before and after surgery and an intraoperative BP strategy targeting a MAP ≥60 mm Hg.
Primary Outcome Measure Information:
Title
A composite of life-threatening bleeding, major bleeding, and critical organ bleeding
Description
Number of patients who have at least one of the following: life-threatening bleeding, major bleeding, and critical organ bleeding
Time Frame
30 days after randomization
Title
A composite of MINS, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism.
Description
Number of patients who have at least one of the following: myocardial injury after noncardiac surgery, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism.
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: A composite of vascular death, non-fatal MINS, non-fatal stroke, and non-fatal cardiac arrest.
Description
Number of patients enrolled in the blood pressure management arm who have at least one of the following: vascular death, non-fatal myocardial injury after noncardiac surgery, non-fatal stroke, and non-fatal cardiac arrest.
Time Frame
30 days after randomization
Secondary Outcome Measure Information:
Title
A net risk-benefit outcome as a composite of vascular death, and non-fatal life-threatening,major or critical organ bleeding,MINS,stroke,peripheral arterial thrombosis,and symptomatic proximal venous thromboembolism
Description
Number of patients who have at least one of the following: vascular death, and non-fatal life-threatening, major or critical organ bleeding, myocardial injury after noncardiac surgery, stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism,
Time Frame
30 days after randomization
Title
BIMS
Description
Number of patients who experience bleeding independently associated with mortality after noncardiac surgery (BIMS)
Time Frame
30 days after randomization
Title
MINS
Description
Number of patients who experience a myocardial injury after noncardiac surgery (MINS)
Time Frame
30 days after randomization
Title
MINS not fulfilling the universal definition of myocardial infarction
Description
Number of patients who experience a myocardial injury after noncardiac surgery (MINS) not fulfilling the 3rd universal definition of myocardial infarction
Time Frame
30 days after randomization
Title
Myocardial infarction
Description
Number of patients who experience a myocardial infarction
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: all-cause mortality
Description
Number of patients who die of any cause
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: MINS
Description
Number of patients who experience a myocardial injury after noncardiac surgery (MINS)
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: Myocardial infarction
Description
Number of patients who experience a myocardial infarction
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: MINS not fulfilling the universal definition of myocardial infarction
Description
Number of patients who experience MINS not fulfilling the universal definition of myocardial infarction
Time Frame
30 days after randomization
Other Pre-specified Outcome Measures:
Title
Life threatening bleeding
Description
Number of patients who experience a life threatening bleed.
Time Frame
30 days after randomization
Title
Major bleeding
Description
Number of patients who experience a major bleed.
Time Frame
30 days after randomization
Title
Critical organ bleeding
Description
Number of patients who experience bleeding in a critical organ.
Time Frame
30 days after randomization
Title
International Society on Thrombosis and Haemostasis (ISTH) major bleeding
Description
Number of patients who experience an International Society on Thrombosis and Haemostasis (ISTH) major bleeding
Time Frame
30 days after randomization
Title
Non-hemorrhagic stroke
Description
Number of patients who experience a non-hemorrhagic stroke
Time Frame
30 days after randomization
Title
Peripheral arterial thrombosis
Description
Number of patients who experience peripheral arterial thrombosis
Time Frame
30 days after randomization
Title
Symptomatic proximal venous thromboembolism
Description
Number of patients who experience a symptomatic proximal venous thromboembolism
Time Frame
30 days after randomization
Title
All-cause mortality
Description
Number of patients who die of any cause
Time Frame
30 days after randomization
Title
Vascular mortality
Description
Number of patients who die of vascular cause
Time Frame
30 days after randomization
Title
Hemorrhagic stroke
Description
Number of patients who experience a hemorrhagic stroke
Time Frame
30 days after randomization
Title
Transfusion rate
Description
Rate of transfusion in patients who experience a major bleeding event
Time Frame
30 days after randomization
Title
Cardiac revascularization
Description
Number of patients who have undergo cardiac revascularization
Time Frame
30 days after randomization
Title
Amputation
Description
Number of patients who have an amputation
Time Frame
30 days after randomization
Title
Symptomatic pulmonary embolism
Description
Number of patients who experience a symptomatic pulmonary embolism
Time Frame
30 days after randomization
Title
Symptomatic proximal DVT
Description
Number of patients who experience a symptomatic proximal DVT
Time Frame
30 days after randomization
Title
Any symptomatic or asymptomatic proximal venous thromboembolism
Description
Number of patients who experience any (symptomatic or asymptomatic) proximal venous thromboembolism
Time Frame
30 days after randomization
Title
Acute kidney injury
Description
Number of patients who experience an acute kidney injury
Time Frame
30 days after randomization
Title
New renal replacement therapy
Description
Number of patients who require new renal replacement therapy
Time Frame
30 days after randomization
Title
Re-hospitalization for vascular reasons
Description
Number of patients who experience a re-hospitalization for vascular reasons
Time Frame
30 days after randomization
Title
Seizures
Description
Number of patients who experience a seizure
Time Frame
30 days after randomization
Title
Infection/sepsis
Description
Number of patients who experience infection/sepsis
Time Frame
30 days after randomization
Title
Disability
Description
Number of patients who experience disability (based on 12-item WHO Disability Assessment Schedule [WHODAS 2.0]).
Time Frame
30 days after randomization
Title
Length of hospital stay
Description
Average length of hospital stay
Time Frame
30 days after randomization
Title
Days alive and at home
Description
Number of days alive and at home
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: vascular death
Description
Number of patients who die from a vascular cause
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: non-fatal MINS
Description
Number of patients who experience a non-fatal MINS
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: non-fatal stroke
Description
Number of patients who experience a non-fatal stroke
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: non-fatal cardiac arrest
Description
Number of patients who experience non-fatal cardiac arrest
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: hemorrhagic stroke
Description
Number of patients who experience a hemorrhagic stroke
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: non-hemorrhagic stroke
Description
Number of patients who experience a non-hemorrhagic stroke
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: acute kidney injury
Description
Number of patients who experience an acute kidney injury
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: new renal replacement therapy
Description
Number of patients with new requirement for renal replacement therapy
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: acute congestive heart failure
Description
Number of patients who experience acute congestive heart failure
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: new clinically important atrial fibrillation
Description
Number of patients who experience new clinically important atrial fibrillation
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: sepsis
Description
Number of patients who experience a sepsis event
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: disability
Description
Number of patients who experience disability (based on 12-item WHO Disability Assessment Schedule [WHODAS 2.0]).
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: cancellation/postponement of surgery on the day of surgery due to BP concerns
Description
Number of patients whose surgery was cancelled/postponed on the day of surgery due to BP concerns
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: length of hospital stay
Description
Average length of hospital stay required
Time Frame
30 days after randomization
Title
For patients in the blood pressure management arm: days alive and at home
Description
Number of days alive and at home
Time Frame
30 days after randomization
Title
All-cause mortality
Description
Number of patients who die of any cause
Time Frame
1 year after randomization
Title
Vascular mortality
Description
Number of patients who die of vascular cause
Time Frame
1 year after randomization
Title
Myocardial infarction
Description
Number of patients who experience a myocardial infarction
Time Frame
1 year after randomization
Title
Cardiac arrest
Description
Number of patients who experience cardiac arrest
Time Frame
1 year after randomization
Title
Hemorrhagic stroke
Description
Number of patients who experience a hemorrhagic stroke
Time Frame
1 year after randomization
Title
Non-hemorrhagic stroke
Description
Number of patients who experience a non-hemorrhagic stroke
Time Frame
1 year after randomization
Title
Peripheral arterial thrombosis
Description
Number of patients who experience peripheral arterial thrombosis
Time Frame
1 year after randomization
Title
Amputation
Description
Number of patients who had an amputation
Time Frame
1 year after randomization
Title
Symptomatic pulmonary embolism
Description
Number of patients who experience a symptomatic pulmonary embolism
Time Frame
1 year after randomization
Title
Symptomatic proximal DVT
Description
Number of patients who experience a symptomatic proximal DVT
Time Frame
1 year after randomization
Title
Symptomatic proximal venous thromboembolism
Description
Number of patients who experience a symptomatic proximal venous thromboembolism
Time Frame
1 year after randomization
Title
Any symptomatic or asymptomatic proximal venous thromboembolism
Description
Number of patients who experience any symptomatic or asymptomatic proximal venous thromboembolism
Time Frame
1 year after randomization
Title
New renal replacement therapy
Description
Number of patients who require new renal replacement therapy
Time Frame
1 year after randomization
Title
Re-hospitalization for vascular reasons
Description
Number of patients re-hospitalized for vascular reasons
Time Frame
1 year after randomization
Title
Seizures
Description
Number of patients who experience a seizure
Time Frame
1 year after randomization
Title
Infection/sepsis
Description
Number of patients who experience an infection and/or sepsis event
Time Frame
1 year after randomization
Title
Disability
Description
Number of patients who experience disability (based on 12-item WHO Disability Assessment Schedule [WHODAS 2.0]).
Time Frame
1 year after randomization
Title
For patients in the blood pressure management arm: all-cause mortality
Description
Number of patients who die of any cause
Time Frame
1 year after randomization
Title
For patients in the blood pressure management arm: vascular mortality
Description
Number of patients who die of a vascular cause
Time Frame
1 year after randomization
Title
For patients in the blood pressure management arm: myocardial infarction
Description
Number of patients who experience a myocardial infarction
Time Frame
1 year after randomization
Title
For patients in the blood pressure management arm: cardiac arrest
Description
Number of patients who experience cardiac arrest
Time Frame
1 year after randomization
Title
For patients in the blood pressure management arm: hemorrhagic stroke
Description
Number of patients who experience a hemorrhagic stroke
Time Frame
1 year after randomization
Title
For patients in the blood pressure management arm: non-hemorrhagic stroke
Description
Number of patients who experience a non-hemorrhagic stroke
Time Frame
1 year after randomization
Title
For patients in the blood pressure management arm: new renal replacement therapy
Description
Number of patients who require new renal replacement therapy
Time Frame
1 year after randomization
Title
For patients in the blood pressure management arm: acute congestive heart failure
Description
Number of patients who experience acute congestive heart failure
Time Frame
1 year after randomization
Title
For patients in the blood pressure management arm: sepsis
Description
Number of patients who experience a sepsis event
Time Frame
1 year after randomization
Title
For patients in the blood pressure management arm: Disability
Description
Number of patients who experience disability (based on 12-item WHO Disability Assessment Schedule [WHODAS 2.0]).
Time Frame
1 year after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Undergoing noncardiac surgery; ≥ 45 years of age; Expected to require at least an overnight hospital admission after surgery; Provide written informed consent to participate in the POISE-3 Trial, AND Fulfill ≥1 of the following 6 criteria (A-F): A. NT-proBNP ≥200 ng/L B. History of coronary artery disease C. History of peripheral arterial disease D. History of stroke E. Undergoing major vascular surgery; OR F. Any 3 of 9 risk criteria i. Undergoing major surgery; ii. History of congestive heart failure; iii. History of a transient ischemic attack; iv. Diabetes and currently taking an oral hypoglycemic agent or insulin; v. Age >70 years; vi. History of hypertension; vii. Serum creatinine > 175 µmol/L (> 2.0 mg/dl); viii. History of smoking within 2 years of surgery; ix. Undergoing emergent/urgent surgery. Exclusion criteria: Patients undergoing cardiac surgery Patients undergoing cranial neurosurgery Planned use of systemic TXA during surgery Low-risk surgical procedure (based on individual physician's judgment) Hypersensitivity or known allergy to TXA Creatinine clearance <30 mL/min (Cockcroft-Gault equation) or on chronic dialysis History of seizure disorder Patients with recent stroke, myocardial infarction, acute arterial thrombosis or venous thromboembolism (<3 month) Patients with fibrinolytic conditions following consumption coagulopathy Patients with subarachnoid hemorrhage within the past 30 days Women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding Previously enrolled in POISE-3 Trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PJ Devereaux, MD, PhD
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Cleveland Clinic, Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7010
Country
United States
Facility Name
Wake Forest
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic - Fairview
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Cleveland Clinic - Main Campus
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Cleveland Clinic - Hillcrest
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Queen Elizabeth II Jubilee Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4108
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
Country
Australia
Facility Name
Eastern Health (Box Hill Hospital)
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
Dandenong Hospital
City
Dandenong
State/Province
Victoria
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
Country
Australia
Facility Name
Western Health
City
Footscray
Country
Australia
Facility Name
Peter MacCallum Hospital
City
Melbourne
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton
Country
Australia
Facility Name
Royal Perth
City
Perth
Country
Australia
Facility Name
Princes of Wales Hospital
City
Randwick
Country
Australia
Facility Name
Goulburn Valley Health
City
Shepparton
Country
Australia
Facility Name
Westmead Hospital
City
Sydney
Country
Australia
Facility Name
Medical University of Vienna
City
Vienna
Country
Austria
Facility Name
CHU Brugmann
City
Brussels
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
Country
Belgium
Facility Name
Hospital do Coracao de Pocos de Caldas
City
Poços De Caldas
State/Province
Minas Gerais
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
Country
Brazil
Facility Name
University of Calgary, O'Brien Institute for Public Health
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Juravinski Hospital & Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Kingston Health Sciences Centre
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
University Health Network (Toronto General Hospital)
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
CHUM
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Sherbrooke
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Royal University Hospital (Saskatoon)
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Victoria Hospital
City
London
Country
Canada
Facility Name
Clinica Santa Maria
City
Santiago
Country
Chile
Facility Name
Hospital Hernan Henriquez
City
Temuco
Country
Chile
Facility Name
Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
The Fourth Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Bispebjerg Hospital
City
Copenhagen
State/Province
Capital Region
Country
Denmark
Facility Name
Rigshospitalet, Abdominal Centre
City
Copenhagen
Country
Denmark
Facility Name
Zealand University Hospital
City
Køge
Country
Denmark
Facility Name
Groupe Hospitalier Paris Saint Joseph
City
Paris
Country
France
Facility Name
University Hospital RWTH Aachen
City
Aachen
Country
Germany
Facility Name
University Hospital Bonn
City
Bonn
Country
Germany
Facility Name
Klinikum Dortmund gGmbH
City
Dortmund
Country
Germany
Facility Name
University Hospital Düsseldorf
City
Düsseldorf
Country
Germany
Facility Name
Prince of Wales Hospital
City
Sha Tin
Country
Hong Kong
Facility Name
Surat Institute of Digestive Science
City
Surat
State/Province
Gujarat
Country
India
Facility Name
Sumandeep Vidyapeeth & Dhiraj General Hospital
City
Vadodara
State/Province
Gujurat
Country
India
Facility Name
Nanjappa Hospital
City
Shimoga
State/Province
Karnataka
Country
India
Facility Name
Government Medical College
City
Trivandrum
State/Province
Kerala
ZIP/Postal Code
695011
Country
India
Facility Name
Rahate Surgical Hospital
City
Nagpur
State/Province
Maharashtra
Country
India
Facility Name
Sengupta Hospital & Research Institute
City
Nagpur
State/Province
Maharashtra
Country
India
Facility Name
AMAI Charitable Trust's Ace Hospital
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
Sidhu Hospital Pvt. Ltd.
City
Doraha
State/Province
Punjab
Country
India
Facility Name
Christian Medical College, Ludhiana
City
Ludhiana
State/Province
Punjab
Country
India
Facility Name
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow
City
Lucknow
State/Province
Uttar Pradesh
Country
India
Facility Name
NH Rabindranath Tagore International Inst. of Cardiac Sciences
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700099
Country
India
Facility Name
TD Medical College
City
Alappuzha
Country
India
Facility Name
Bangalore Baptist Hospital
City
Bangalore
Country
India
Facility Name
Ospedale Galliera di Genova
City
Genova
Country
Italy
Facility Name
IRCCS Galeazzi Orthopedic Institute
City
Milano
Country
Italy
Facility Name
Instituto Clinico San Siro
City
Milan
Country
Italy
Facility Name
IRCCS San Raffaele Scientific Institute
City
Milan
Country
Italy
Facility Name
Port Dickson Hospital
City
Port Dickson
State/Province
Negeri Sembilan
Country
Malaysia
Facility Name
Sarawak General Hospital
City
Kuching
State/Province
Sarawak
Country
Malaysia
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
Country
Malaysia
Facility Name
Hospital Pulau Pinang
City
Pulau Pinang
Country
Malaysia
Facility Name
Sungai Buloh Hospital
City
Sungai Buloh
Country
Malaysia
Facility Name
Deventer Ziekenhuis
City
Deventer
State/Province
Overijssel
Country
Netherlands
Facility Name
Erasmus University Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
Auckland General Hospital
City
Grafton
State/Province
Auckland
Country
New Zealand
Facility Name
Middlemore Hospital
City
Auckland
Country
New Zealand
Facility Name
Waikato District Health Board
City
Hamilton
Country
New Zealand
Facility Name
Shifa International Hospitals
City
Islamabad
State/Province
Islamabad Capital Territory
Country
Pakistan
Facility Name
Aga Khan University
City
Karachi
Country
Pakistan
Facility Name
Jagiellonian University Medical College
City
Kraków
Country
Poland
Facility Name
Specialistyczny Szpital im. E. Szczeklika w Tarnowie
City
Tarnów
Country
Poland
Facility Name
Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Górze
City
Zielona Góra
Country
Poland
Facility Name
City Hospital 1 of Arkhangelsk
City
Arkhangelsk
Country
Russian Federation
Facility Name
V. Negovskiy Reanimatology Research Institute
City
Moscow
ZIP/Postal Code
107031
Country
Russian Federation
Facility Name
Moscow Regional Research & Clinical Institute (MONIKI)
City
Moscow
Country
Russian Federation
Facility Name
City Hospital N25
City
Novosibirsk
Country
Russian Federation
Facility Name
E. Meshalkin National Medical Research Center
City
Novosibirsk
Country
Russian Federation
Facility Name
Hospital of Saint-Petersburg State University
City
Saint Petersburg
Country
Russian Federation
Facility Name
Tyumen State Medical University
City
Tyumen
Country
Russian Federation
Facility Name
Groote Schuur Hospital
City
Observatory
State/Province
Cape Town
Country
South Africa
Facility Name
Sefako Makgatho Health Sciences University (SMU)
City
Ga-Rankuwa
State/Province
Gauteng
Country
South Africa
Facility Name
Steve Biko Academic Hospital - University of Pretoria
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Hospital Clinic - Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital de la Sta Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Vall D'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Dr. Josep Trueta
City
Girona
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Fundacion Alcorcon
City
Madrid
Country
Spain
Facility Name
Hospital Clínico Universitario in Valladolid
City
Valladolid
Country
Spain
Facility Name
Medway NHS Foundation Trust
City
Gillingham
Country
United Kingdom
Facility Name
Chelsea & Westminster Hospital
City
London
Country
United Kingdom
Facility Name
West Middlesex Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35363452
Citation
Devereaux PJ, Marcucci M, Painter TW, Conen D, Lomivorotov V, Sessler DI, Chan MTV, Borges FK, Martinez-Zapata MJ, Wang CY, Xavier D, Ofori SN, Wang MK, Efremov S, Landoni G, Kleinlugtenbelt YV, Szczeklik W, Schmartz D, Garg AX, Short TG, Wittmann M, Meyhoff CS, Amir M, Torres D, Patel A, Duceppe E, Ruetzler K, Parlow JL, Tandon V, Fleischmann E, Polanczyk CA, Lamy A, Astrakov SV, Rao M, Wu WKK, Bhatt K, de Nadal M, Likhvantsev VV, Paniagua P, Aguado HJ, Whitlock RP, McGillion MH, Prystajecky M, Vincent J, Eikelboom J, Copland I, Balasubramanian K, Turan A, Bangdiwala SI, Stillo D, Gross PL, Cafaro T, Alfonsi P, Roshanov PS, Belley-Cote EP, Spence J, Richards T, VanHelder T, McIntyre W, Guyatt G, Yusuf S, Leslie K; POISE-3 Investigators. Tranexamic Acid in Patients Undergoing Noncardiac Surgery. N Engl J Med. 2022 May 26;386(21):1986-1997. doi: 10.1056/NEJMoa2201171. Epub 2022 Apr 2.
Results Reference
derived
PubMed Identifier
35101083
Citation
Marcucci M, Painter TW, Conen D, Leslie K, Lomivorotov VV, Sessler D, Chan MTV, Borges FK, Martinez Zapata MJ, Wang CY, Xavier D, Ofori SN, Landoni G, Efremov S, Kleinlugtenbelt YV, Szczeklik W, Schmartz D, Garg AX, Short TG, Wittmann M, Meyhoff CS, Amir M, Torres D, Patel A, Duceppe E, Ruetzler K, Parlow JL, Tandon V, Wang MK, Fleischmann E, Polanczyk CA, Jayaram R, Astrakov SV, Rao M, VanHelder T, Wu WKK, Cheong CC, Ayad S, Abubakirov M, Kirov M, Bhatt K, de Nadal M, Likhvantsev V, Iglesisas PP, Aguado HJ, McGillion M, Lamy A, Whitlock RP, Roshanov P, Stillo D, Copland I, Vincent J, Balasubramanian K, Bangdiwala SI, Biccard B, Kurz A, Srinathan S, Petit S, Eikelboom J, Richards T, Gross PL, Alfonsi P, Guyatt G, Belley-Cote E, Spence J, McIntyre W, Yusuf S, Devereaux PJ. Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery. Trials. 2022 Jan 31;23(1):101. doi: 10.1186/s13063-021-05992-1.
Results Reference
derived

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PeriOperative ISchemic Evaluation-3 Trial

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