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NCT Number: NCT04803747

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

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

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Key information

Conditions

Major Non-cardiac Surgeries Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Grace Hospital, Winnipeg, Manitoba, Canada

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About this study

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. 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:

  • Proportion of patients transfused RBCs
  • Incidence of DVT or PE (collectively called venous thromboembolism (VTE) within 90 days of surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • Active thromboembolic disease (i.e., arterial or venous thrombosis within 90 days preoperative)
  • 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.

Treatment and study plan

Tranexamic acid (TXA)

Drug

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 (0.9 % saline)

Drug

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).

Primary outcomes

  1. Proportion of patients transfused RBCs

    Time frame: From date of surgery until the date of hospital discharge, assessed up to 90 days

    Proportion of patients requiring transfused RBCs

  2. Incidence of DVT or PE (collectively called venous thromboembolism (VTE)

    Time frame: Within 90 days of surgery

    Number of patients with VTE events

Secondary outcomes

  1. Transfused units

    Time frame: From date of surgery until 3 days post-operative, 7 days post-operative, and until the date of hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.

    The number of RBC units transfused (both at hospital level and patient level).

  2. Arterial event - myocardial infarction

    Time frame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.

    Secondary safety outcomes include the in-hospital diagnosis of myocardial infarction

  3. Arterial event - stroke

    Time frame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.

    Secondary safety outcomes include the in-hospital diagnosis of stroke

  4. Venous thrombotic event - deep vein thrombosis

    Time frame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.

    Secondary safety outcomes include the in-hospital diagnosis of deep vein thrombosis

  5. Venous thrombotic event - pulmonary embolus

    Time frame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.

    Secondary safety outcomes include the in-hospital diagnosis of pulmonary embolus

  6. Length of hospitalization

    Time frame: Length of index hospital admission

    Hospital length of stay

  7. Intensive care unit (ICU) admission

    Time frame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.

    Proportion of participants requiring ICU admission

  8. Hospital survival

    Time frame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.

    Proportion of patients alive at hospital discharge

  9. 90 day survival

    Time frame: Up to day 30

    Survival at 90-days post-operative

  10. Compliance

    Time frame: Intraoperative

    The proportion of enrolled patients who receive a minimum of one dose of the study intervention

  11. Clinical -a patient centered outcome

    Time frame: Up to day 30 postoperative

    Number of days alive and out of hospital 30 (a patient-centered outcome, that integrates length of stay, readmission and early deaths after surgery into a single outcome metric

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

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

Registry information

Official study 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

Acronym: TRACTION

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2021
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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