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

• Status: Not yet recruiting
• Trial end date: 2021-11-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Manitoba
• Collaborators: Canadian Institutes of Health Research (CIHR); Health Sciences Centre Foundation, Manitoba; The Ottawa Hospital
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• 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 and with increased local fibrinolysis undergoing surgery (a state necessarily indicative of hyperfibrinolysis). To observe measurable effect of tranexamic acid on RBC transfusion we will include hospital procedures known to be associated with a baseline RBC transfusion rate of ≥ 5%. This threshold was chosen as both clinicians and our patient partners identified that a 1 in 20 chance of transfusion was substantive, and to ensure inclusion of a sufficiently broad patient population.

Classification of major non-cardiac surgeries to include:

1. 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)

2. Orthopedics (hip fracture repair, pelvic fixation, femur repair / fixation, shoulder / humerus open reduction internal fixation, lower extremity amputation)

3. Spine (spinal fusion, vertebrectomy and diskectomy with instrumentation)

4. Otolaryngology (glossectomy, mandibulectomy, radical laryngectomy)

5. Thoracic (lung resection or decortication)

6. Vascular (large vessel arterial bypass, large vessel aneurysmorrhaphy, large vessel endarterectomy)

7. Gynecology (hysterectomy)

8. Urology (nephrectomy, cystectomy, prostatectomy, pelvic exenteration)

9. Plastic surgery (neoplasm resection, soft tissue resection, skin grafting)

10. 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