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

  • STATUS
    Recruiting
  • End date
    Apr 15, 2023
  • participants needed
    8320
  • sponsor
    University of Manitoba
Updated on 19 April 2022

Summary

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

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.

Details
Condition Major Non-cardiac Surgeries
Treatment Tranexamic Acid (TXA), Placebo (0.9 % Saline)
Clinical Study IdentifierNCT04803747
SponsorUniversity of Manitoba
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

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)
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)
Orthopedics (hip fracture repair, pelvic fixation, femur repair / fixation, shoulder
humerus open reduction internal fixation, lower extremity amputation)
Spine (vertebrectomy, surgery involving >/= 3 levels)
Otolaryngology (glossectomy, mandibulectomy, radical laryngectomy)
Thoracic (lung resection or decortication)
Vascular (arterial bypass / endarterectomy / aneurysmorrhaphy involving the aorta or
proximal vessels off the aorta)
Gynecology (hysterectomy)
Urology (nephrectomy, cystectomy, prostatectomy, pelvic exenteration)
Plastic surgery (large neoplasm resections, burns or debridements)
Surgeries anticipated

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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