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CompletedPhase 4

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

Key facts

Who runs it
University of Manitoba
Where
Canada10 sites in 1 countryChoose a country to see its sites
Trial code
Status
Completed
Phase
Phase 4
People taking part
8,421 people enrolled
Started
16 Feb 2022
Ended
3 Jun 2024
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Tranexamic acid (TXA)
  • Placebo (0.9 % Saline)
Record updated
22 January 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 20 criteriaShow less

Who cannot take part

  • Trauma surgeries where TXA was administered within the previous 3 hours
  • Active thromboembolic disease (i.e., arterial or venous thrombosis within 90 days preoperative)
  • Cardiac surgery and hip and knee arthroplasty where TXA is standard-of-care
  • Pregnancy
  • Surgeries with free flap reconstruction

Other criteria

  • Cluster-level inclusion criteria:
  • Hospital sites will be included in the trial if the site performs ≥ 100 noncardiac surgeries per month, and if anesthesia, surgery 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 to be associated with 5% or greater risk of RBC transfusion in hospital as per the surgical team

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Tranexamic acid (TXA) ArmExisting treatment, for comparison

    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).

    Treatment: Tranexamic acid (TXA)

  • Placebo ArmPlacebo, for comparison

    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).

    Treatment: Placebo (0.9 % Saline)

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Publications
Record updated
22 January 2026