A Trial of a Hospital Policy of Tranexamic Acid Use to Reduce Transfusion in Major Non-cardiac Surgery (TRACTION)

April 20, 2023 updated by: Dr. Ryan Zarychanski, University of Manitoba

A Phase IV Trial of a Hospital Policy of Tranexamic Acid Use to Reduce Transfusion in Major Non-cardiac Surgery (TRACTION): A Pragmatic Randomized Cluster Crossover Trial

A Phase IV trial of a hospital policy of Tranexamic acid to reduce transfusion in major non-cardiac surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The TRACTION Trial is a national multi-centre Phase IV randomized cluster-crossover trial of Tranexamic acid versus placebo. Over the duration of the study, participating centres will be centrally and randomly allocated to receive either TXA or matching placebo at 1-month intervals for a total of 8 months. As our pragmatic trial is designed to define practice, we have selected co-primary outcomes that evaluate effectiveness in the context of safety.

Our co-primary outcomes are the:

  1. Proportion of patients transfused RBCs
  2. Incidence of DVT or PE (collectively called venous thromboembolism (VTE) within 3 months of surgery.

Study Type

Interventional

Enrollment (Anticipated)

8320

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • Recruiting
        • St. Boniface Hospital
        • Sub-Investigator:
          • Hema Bagry
      • Winnipeg, Manitoba, Canada, R3J 3M7
        • Recruiting
        • Grace Hospital
        • Sub-Investigator:
          • Jayesh Daya
      • Winnipeg, Manitoba, Canada, R3E 0W2
        • Recruiting
        • University of Manitoba- HSC Campus
        • Sub-Investigator:
          • Marshall Tenenbein, MD
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
      • London, Ontario, Canada, N6A 5A5
      • Ottawa, Ontario, Canada, K1K 0T2
      • Ottawa, Ontario, Canada, K1H8L6
        • Recruiting
        • Ottawa Hospital Research Institute- Civic and General sites
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dean Fergusson, MD
      • Sudbury, Ontario, Canada, P3E 5J1
        • Recruiting
        • Health Sciences North Research Institute
        • Contact:
        • Principal Investigator:
          • Sarah McIsaac
        • Sub-Investigator:
          • Kait Duncan
      • Toronto, Ontario, Canada, M3M 0B2
        • Recruiting
        • Humber River Hospital
        • Contact:
        • Principal Investigator:
          • Sinziana Avramescu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Cluster-level inclusion criteria:

Hospital sites will be included in the trial if anesthesia and hospital leadership agree to manage patients as per the policy being implemented and evaluated in the trial.

Patient-level inclusion criteria:

  • Patients >/= 18 years of age undergoing major non-cardiac surgery (a state of hyperfibrinolysis)
  • Inpatient surgeries with an estimated >/= 5% risk of RBC transfusion, including open surgeries or laparoscopic surgeries with an estimated duration of >/= 3 hours

Examples of eligible surgeries could include (but are not limited to):

  1. General surgery (esophagectomy, gastrectomy, gastric repair, small bowel repair or resection, ostomy formation, colon/rectum repair or resection, colostomy, splenectomy, hepatectomy, pancreatectomy, resection of abdominal mass)
  2. Orthopedics (hip fracture repair, pelvic fixation, femur repair / fixation, shoulder / humerus open reduction internal fixation, lower extremity amputation)
  3. Spine (vertebrectomy, surgery involving >/= 3 levels)
  4. Otolaryngology (glossectomy, mandibulectomy, radical laryngectomy)
  5. Thoracic (lung resection or decortication)
  6. Vascular (arterial bypass / endarterectomy / aneurysmorrhaphy involving the aorta or proximal vessels off the aorta)
  7. Gynecology (hysterectomy)
  8. Urology (nephrectomy, cystectomy, prostatectomy, pelvic exenteration)
  9. Plastic surgery (large neoplasm resections, burns or debridements)
  10. Surgeries anticipated to be associated with 5% or greater risk of RBC transfusion in hospital as per the surgical team.

Exclusion Criteria:

  • Active thromboembolic disease (ie, patient is anticoagulated for thromboembolic disease prior to admission)
  • Pregnancy
  • Cardiac surgery and hip and knee arthroplasty where TXA is standard-of-care
  • Surgeries with free flap reconstruction
  • Trauma surgeries where TXA was administered within the previous 3 hours.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tranexamic acid (TXAl Arm
TXA 1 gram bolus (2 grams for patients over 100 kg) intravenously (IV) administered within 10 minutes of the first surgical incision, followed by 1 additional gram given intravenously at 2-4 hours of surgery or prior to skin closure, at the discretion of the anesthesiologist (e.g. IV bolus at 2-4 hours of surgery, at skin closure, or the 1 additional gram given as a continuous infusion throughout the surgical procedure).
Drug: Tranexamic acid (TXA)
TXA 1 gram bolus (2 grams for patients over 100 kg) intravenously (IV) administered within 10 minutes of the first surgical incision, followed by 1 additional gram given intravenously at 2-4 hours of surgery or prior to skin closure, at the discretion of the anesthesiologist (e.g. IV bolus at 2-4 hours of surgery, at skin closure, or the 1 additional gram given as a continuous infusion throughout the surgical procedure).
Placebo Comparator: Placebo Arm
Placebo 1 gram bolus (2 grams for patients over 100 kg) intravenously (IV) administered within 10 minutes of the first surgical incision, followed by 1 additional gram given intravenously at 2-4 hours of surgery or prior to skin closure, at the discretion of the anesthesiologist (e.g. IV bolus at 2-4 hours of surgery, at skin closure, or the 1 additional gram given as a continuous infusion throughout the surgical procedure).
Drug: Placebo (0.9 % Saline)
Placebo (0.9 % normal saline) 1 gram bolus (2 grams for patients over 100 kg) intravenously (IV) administered within 10 minutes of the first surgical incision, followed by 1 additional gram given intravenously at 2-4 hours of surgery or prior to skin closure, at the discretion of the anesthesiologist (e.g. IV bolus at 2-4 hours of surgery, at skin closure, or the 1 additional gram given as a continuous infusion throughout the surgical procedure).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of RBC Transfusions
Time Frame: Randomization through hospital discharge, anticipated less than 7 days.
Number of patients requiring transfused RBCs.
Randomization through hospital discharge, anticipated less than 7 days.
Incidence of DVT or PE (collectively called venous thromboembolism (VTE)
Time Frame: Within 3 months of surgery.
Number of patients with VTE events
Within 3 months of surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transfused units
Time Frame: Randomization through hospital discharge, anticipated less than 7 days.
The number of RBC units transfused (both at cluster level and patient level).
Randomization through hospital discharge, anticipated less than 7 days.
Arterial or Venous thrombotic events
Time Frame: Randomization through hospital discharge, anticipated less than 7 days.
Secondary safety outcomes include the in-hospital diagnosis of myocardial infarction, stroke, deep vein thrombosis or pulmonary embolus.
Randomization through hospital discharge, anticipated less than 7 days.
Clinical
Time Frame: During hospital stay up to 90 days
Hospital length of stay
During hospital stay up to 90 days
Clinical
Time Frame: During hospital stay up to 90 days
Number of participants requiring ICU admission
During hospital stay up to 90 days
Clinical
Time Frame: During hospital stay up to 90 days
3-month survival
During hospital stay up to 90 days
the number of days at home to day 30 (DAH30)
Time Frame: up to day 30
the number of days at home to day 30 (DAH30)
up to day 30
Compliance
Time Frame: Randomization through hospital discharge, anticipated less than 7 days.
Proportion of eligible patients who receive the policy intervention, and the policy compliance
Randomization through hospital discharge, anticipated less than 7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

Canadian Institutes of Health Research (CIHR)
Health Sciences Centre Foundation, Manitoba
The Ottawa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2022

Primary Completion (Anticipated)

December 16, 2023

Study Completion (Anticipated)

February 15, 2024

Study Registration Dates

First Submitted

February 1, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TXA-51231

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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