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Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery (TRIGS)

Primary Purpose

Infection Wound, Gastrointestinal Complication, Anesthesia

Status
Recruiting
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Tranexamic Acid
Placebos
Sponsored by
Bayside Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection Wound

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. Adult patients scheduled for elective or semi-elective (inpatient) open or lap-assisted GI surgery (oesophageal, gastric, hepatobiliary, colorectal) with one or more risk factors for complications:

  • Age ≥70 years
  • ASA physical status 3 or 4
  • Known or suspected history of: heart failure, diabetes, peripheral vascular disease, or chronic respiratory disease
  • Obesity (BMI ≥30 kg/m2)
  • Anaemia (preoperative haemoglobin <130 g/l in males and <120 g/l in females)
  • Renal impairment (se. creatinine ≥150mol/l)
  • Low albumin (<30 g/L)

Exclusion Criteria:

  • Poor spoken and or written language comprehension
  • Laparoscopic cholecystectomy and other minor (eg. closure of stoma) surgery
  • Pre-existing infection/sepsis
  • Known history of: spontaneous pulmonary embolism, arterial thrombosis familial thrombophilia (e.g. Lupus anticoagulant, protein C deficiency, factor V Leiden)

Sites / Locations

  • Alfred HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tranexamic acid

Placebo

Arm Description

At induction of anesthesia and prior to surgical incision a bolus of 0.15 ml/kg ( up to a maximum of 15 ml) , and then commence an infusion of 0.05 ml/kg/h until the end of surgery. The total maximal administered study drug volume will be 30 ml.

At induction of anesthesia and prior to surgical incision a bolus of 0.15 ml/kg ( up to a maximum of 15 ml) , and then commence an infusion of 0.05 ml/kg/h until the end of surgery. The total maximal administered study drug volume will be 30 ml.

Outcomes

Primary Outcome Measures

Incidence of Surgical Site Infection
defined by the US Centers for Disease Control (CDC)

Secondary Outcome Measures

Red cell transfusion
Total units given
Other healthcare-associated infections
sepsis, pneumonia, blood stream infection, UTI, etc; all using CDC-guided definitions
C-reactive protein
peak
Days at home up to 30 days after surgery (DAH30).
Time that patient spends at home in the 30 days following surgery

Full Information

First Posted
November 27, 2019
Last Updated
January 9, 2023
Sponsor
Bayside Health
Collaborators
National Health and Medical Research Council, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT04192435
Brief Title
Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery
Acronym
TRIGS
Official Title
Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery; The TRIGS Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayside Health
Collaborators
National Health and Medical Research Council, Australia

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.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This international, multicentre, pragmatic, double-blind, placebo-controlled, randomised trial of TxA versus placebo will enrol 3,300 patients throughout Australia and internationally. This is an effectiveness trial - some elements of the trial are deliberately left to the perioperative clinicians' discretion in order to reflect usual practice and maximise generalisability.
Detailed Description
Study Aims: To conduct a large, multicentre clinical trial of tranexamic acid (TxA), an antifibrinolytic drug routinely used to reduce bleeding in cardiac and some orthopaedic surgery, in 3,300 patients undergoing major gastrointestinal (GI) surgery. Our specific aims are to investigate whether TxA: Aim 1: Reduces surgical site infection ("wound infection"), and other healthcare-associated infections (pneumonia and sepsis). Aim 2: Reduces red cell transfusion in GI surgery. Aim 3: Reduces a pooled composite of any serious postoperative complications, and so increases "days alive and at home up to 30 days after surgery" (DAH30). Aim 4: To evaluate the temporal effect of TxA on perioperative immune and inflammatory responses. Study Hypothesis Prophylactic TxA administration in patients undergoing major GI surgery reduces the incidence of surgical site infection (SSI) after surgery when compared with placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection Wound, Gastrointestinal Complication, Anesthesia, Bleeding, Healthcare Associated Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
double-blind, placebo-controlled, randomised trial of TxA versus placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Matched TxA and placebo vials
Allocation
Randomized
Enrollment
3300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid
Arm Type
Active Comparator
Arm Description
At induction of anesthesia and prior to surgical incision a bolus of 0.15 ml/kg ( up to a maximum of 15 ml) , and then commence an infusion of 0.05 ml/kg/h until the end of surgery. The total maximal administered study drug volume will be 30 ml.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
At induction of anesthesia and prior to surgical incision a bolus of 0.15 ml/kg ( up to a maximum of 15 ml) , and then commence an infusion of 0.05 ml/kg/h until the end of surgery. The total maximal administered study drug volume will be 30 ml.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
100mg/ml
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo will be 5ml vials calculated to equivalent to the 100mg/ml of active drug.
Primary Outcome Measure Information:
Title
Incidence of Surgical Site Infection
Description
defined by the US Centers for Disease Control (CDC)
Time Frame
from surgical incision to 30 days post surgical incision
Secondary Outcome Measure Information:
Title
Red cell transfusion
Description
Total units given
Time Frame
from surgical incision to hospital discharge (from index surgery) or 30 days.
Title
Other healthcare-associated infections
Description
sepsis, pneumonia, blood stream infection, UTI, etc; all using CDC-guided definitions
Time Frame
from surgical incision to 30 days
Title
C-reactive protein
Description
peak
Time Frame
Postoperative Day 3 (three days after surgical incision)
Title
Days at home up to 30 days after surgery (DAH30).
Description
Time that patient spends at home in the 30 days following surgery
Time Frame
From surgical incision to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Adult patients scheduled for elective or semi-elective (inpatient) open or lap-assisted GI surgery (oesophageal, gastric, hepatobiliary, colorectal) with one or more risk factors for complications: Age ≥70 years ASA physical status 3 or 4 Known or suspected history of: heart failure, diabetes, peripheral vascular disease, or chronic respiratory disease Obesity (BMI ≥30 kg/m2) Anaemia (preoperative haemoglobin <130 g/l in males and <120 g/l in females) Renal impairment (se. creatinine ≥150mol/l) Low albumin (<30 g/L) Exclusion Criteria: Poor spoken and or written language comprehension Laparoscopic cholecystectomy and other minor (eg. closure of stoma) surgery Pre-existing infection/sepsis Known history of: spontaneous pulmonary embolism, arterial thrombosis familial thrombophilia (e.g. Lupus anticoagulant, protein C deficiency, factor V Leiden)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul S Myles, MD, DSc
Phone
+61390763176
Ext
3176
Email
p.myles@alfred.org.au
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie KA Wallace, MPH, RN
Phone
+61390763176
Ext
62651
Email
s.wallace@alfred.org.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul S Myles, MD, DSc
Organizational Affiliation
Alfred Hospital and Monash University
Official's Role
Study Chair
Facility Information:
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Wallace, MPH
Phone
+61390762651
Ext
62651
Email
s.wallace@alfred.org.au
First Name & Middle Initial & Last Name & Degree
Paul S Myles, MB.BS, MPH, MD,FCARCSI,FANZC

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
This decision will be made on a individual case by case basis, with formal request and review by the PI and steering committee.
IPD Sharing Time Frame
Before recruitment of final patient
IPD Sharing Access Criteria
Patient and illness eligibility
Citations:
PubMed Identifier
31126915
Citation
Draxler DF, Yep K, Hanafi G, Winton A, Daglas M, Ho H, Sashindranath M, Wutzlhofer LM, Forbes A, Goncalves I, Tran HA, Wallace S, Plebanski M, Myles PS, Medcalf RL. Tranexamic acid modulates the immune response and reduces postsurgical infection rates. Blood Adv. 2019 May 28;3(10):1598-1609. doi: 10.1182/bloodadvances.2019000092.
Results Reference
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PubMed Identifier
31317130
Citation
Bell M, Eriksson LI, Svensson T, Hallqvist L, Granath F, Reilly J, Myles PS. Days at Home after Surgery: An Integrated and Efficient Outcome Measure for Clinical Trials and Quality Assurance. EClinicalMedicine. 2019 Apr 27;11:18-26. doi: 10.1016/j.eclinm.2019.04.011. eCollection 2019 May-Jun.
Results Reference
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Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery

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