A Trial of a Hospital Policy of Tranexamic Acid Use to Reduce Transfusion in Major Non-cardiac Surgery
- Conditions
- Major Non-cardiac Surgeries
- Interventions
- Drug: Tranexamic acid (TXA)Drug: Placebo (0.9 % Saline)
- Registration Number
- NCT04803747
- Lead Sponsor
- University of Manitoba
- Brief Summary
A Phase IV trial of a hospital policy of Tranexamic acid to reduce transfusion in major non-cardiac surgery.
- 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 90 days of surgery.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 8440
Not provided
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Tranexamic acid (TXA) Arm 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 Arm Placebo (0.9 % Saline) 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).
- Primary Outcome Measures
Name Time Method Proportion of patients transfused RBCs From date of surgery until the date of hospital discharge, assessed up to 90 days Proportion of patients requiring transfused RBCs
Incidence of DVT or PE (collectively called venous thromboembolism (VTE) Within 90 days of surgery Number of patients with VTE events
- Secondary Outcome Measures
Name Time Method Transfused units 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).
Arterial event - myocardial infarction 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
Arterial event - stroke 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
Venous thrombotic event - deep vein thrombosis 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
Venous thrombotic event - pulmonary embolus 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
Length of hospitalization Length of index hospital admission Hospital length of stay
Intensive care unit (ICU) admission Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days. Proportion of participants requiring ICU admission
Hospital survival Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days. Proportion of patients alive at hospital discharge
90 day survival Up to day 30 Survival at 90-days post-operative
Compliance Intraoperative The proportion of enrolled patients who receive a minimum of one dose of the study intervention
Clinical -a patient centered outcome 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
Trial Locations
- Locations (9)
St. Boniface Hospital
🇨🇦Winnipeg, Manitoba, Canada
Hôpital Montfort
🇨🇦Ottawa, Ontario, Canada
University of Manitoba- HSC Campus
🇨🇦Winnipeg, Manitoba, Canada
Grace Hospital
🇨🇦Winnipeg, Manitoba, Canada
Kingston Health Sciences Centre
🇨🇦Kingston, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Ottawa Hospital Research Institute- Civic and General sites
🇨🇦Ottawa, Ontario, Canada
Humber River Hospital
🇨🇦Toronto, Ontario, Canada
Health Sciences North Research Institute
🇨🇦Sudbury, Ontario, Canada