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Tranexamic Acid in Major Vascular Surgery

Primary Purpose

Blood Loss, Surgical

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
tranexamic acid diluted in 100 ml of saline solution (loading dose)
tranexamic acid undiluted (continous infusion)
Placebo
Sponsored by
IRCCS San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Loss, Surgical

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 50
  • Able to give written informed consent
  • Undergoing open abdominal aortic aneurysm repair

Exclusion Criteria:

  • Patients participating in a pharmaceutical clinical trial in the last 3 months
  • Urgent/emergent surgery
  • Allergy/intolerance to tranexamic acid
  • History of seizures
  • Acute Venous or Arterial Thrombosis
  • Fibrinolytic conditions due to consumption coagulopathy
  • Disseminated intravascular coagulation
  • Haematuria
  • Visual disturbances

Sites / Locations

  • IRCCS San Raffaele Scientific Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic Acid

Placebo

Arm Description

A 500 mg loading dose of tranexamic acid diluted in 100 ml of saline solution will be slowly administered intravenously to patients 20 minutes before surgery, followed by a continuos infusion of 250 mg/h of tranexamic acid from surgical incision until skin closure.

Saline

Outcomes

Primary Outcome Measures

Blood loss (milliliters)

Secondary Outcome Measures

Number of packed blood red cells transfused
Occurrence of thromboembolic events (of any nature)
Mortality

Full Information

First Posted
January 7, 2015
Last Updated
May 12, 2019
Sponsor
IRCCS San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT02335359
Brief Title
Tranexamic Acid in Major Vascular Surgery
Official Title
Tranexamic Acid in Major Vascular Surgery. A Randomized Placebo-controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 4, 2015 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether tranexamic acid is effective in reducing intraoperative blood loss and necessity for haemotransfusion in patients undergoing open abdominal aortic aneurysm repair

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic Acid
Arm Type
Experimental
Arm Description
A 500 mg loading dose of tranexamic acid diluted in 100 ml of saline solution will be slowly administered intravenously to patients 20 minutes before surgery, followed by a continuos infusion of 250 mg/h of tranexamic acid from surgical incision until skin closure.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Drug
Intervention Name(s)
tranexamic acid diluted in 100 ml of saline solution (loading dose)
Intervention Type
Drug
Intervention Name(s)
tranexamic acid undiluted (continous infusion)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline
Primary Outcome Measure Information:
Title
Blood loss (milliliters)
Time Frame
intraoperative (from skin incision to skin closure)
Secondary Outcome Measure Information:
Title
Number of packed blood red cells transfused
Time Frame
hospital stay (an average of one week)
Title
Occurrence of thromboembolic events (of any nature)
Time Frame
28-days and one year after surgery
Title
Mortality
Time Frame
28-days and one year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 50 Able to give written informed consent Undergoing open abdominal aortic aneurysm repair Exclusion Criteria: Patients participating in a pharmaceutical clinical trial in the last 3 months Urgent/emergent surgery Allergy/intolerance to tranexamic acid History of seizures Acute Venous or Arterial Thrombosis Fibrinolytic conditions due to consumption coagulopathy Disseminated intravascular coagulation Haematuria Visual disturbances
Facility Information:
Facility Name
IRCCS San Raffaele Scientific Institute
City
Milan
ZIP/Postal Code
20132
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
31607387
Citation
Monaco F, Nardelli P, Pasin L, Barucco G, Mattioli C, Di Tomasso N, Dalessandro G, Giardina G, Landoni G, Chiesa R, Zangrillo A. Tranexamic acid in open aortic aneurysm surgery: a randomised clinical trial. Br J Anaesth. 2020 Jan;124(1):35-43. doi: 10.1016/j.bja.2019.08.028. Epub 2019 Oct 10.
Results Reference
derived

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Tranexamic Acid in Major Vascular Surgery

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