Status:
ACTIVE_NOT_RECRUITING
A Trial of a Hospital Policy of Tranexamic Acid Use to Reduce Transfusion in Major Non-cardiac Surgery
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Health Sciences Centre Foundation, Manitoba
Conditions:
Major Non-cardiac Surgeries
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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):
- 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 (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.
Exclusion
Key Trial Info
Start Date :
February 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
8440 Patients enrolled
Trial Details
Trial ID
NCT04803747
Start Date
February 16 2022
End Date
October 31 2024
Last Update
May 16 2024
Active Locations (9)
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1
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
2
University of Manitoba- HSC Campus
Winnipeg, Manitoba, Canada, R3E 0W2
3
Grace Hospital
Winnipeg, Manitoba, Canada, R3J 3M7
4
Health Sciences North Research Institute
Greater Sudbury, Ontario, Canada, P3E 5J1