Major Non-cardiac Surgeries Clinical Trial
— TRACTIONOfficial 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
| Verified date | May 2024 |
| Source | University of Manitoba |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A Phase IV trial of a hospital policy of Tranexamic acid to reduce transfusion in major non-cardiac surgery.
| Status | Active, not recruiting |
| Enrollment | 8440 |
| Est. completion date | October 31, 2024 |
| Est. primary completion date | March 5, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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): 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 (vertebrectomy, surgery involving >/= 3 levels) 4. Otolaryngology (glossectomy, mandibulectomy, radical laryngectomy) 5. Thoracic (lung resection or decortication) 6. Vascular (arterial bypass / endarterectomy / aneurysmorrhaphy involving the aorta or proximal vessels off the aorta) 7. Gynecology (hysterectomy) 8. Urology (nephrectomy, cystectomy, prostatectomy, pelvic exenteration) 9. Plastic surgery (large neoplasm resections, burns or debridements) 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 - Surgeries with free flap reconstruction - Trauma surgeries where TXA was administered within the previous 3 hours. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Kingston Health Sciences Centre | Kingston | Ontario |
| Canada | London Health Sciences Centre | London | Ontario |
| Canada | Hôpital Montfort | Ottawa | Ontario |
| Canada | Ottawa Hospital Research Institute- Civic and General sites | Ottawa | Ontario |
| Canada | Health Sciences North Research Institute | Sudbury | Ontario |
| Canada | Humber River Hospital | Toronto | Ontario |
| Canada | Grace Hospital | Winnipeg | Manitoba |
| Canada | St. Boniface Hospital | Winnipeg | Manitoba |
| Canada | University of Manitoba- HSC Campus | Winnipeg | Manitoba |
| Lead Sponsor | Collaborator |
|---|---|
| University of Manitoba | Canadian Institutes of Health Research (CIHR), Health Sciences Centre Foundation, Manitoba, The Ottawa Hospital |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients transfused RBCs | Proportion of patients requiring transfused RBCs | From date of surgery until the date of hospital discharge, assessed up to 90 days | |
| Primary | Incidence of DVT or PE (collectively called venous thromboembolism (VTE) | Number of patients with VTE events | Within 90 days of surgery | |
| Secondary | Transfused units | The number of RBC units transfused (both at hospital level and patient level). | 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. | |
| Secondary | Arterial event - myocardial infarction | Secondary safety outcomes include the in-hospital diagnosis of myocardial infarction | Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days. | |
| Secondary | Arterial event - stroke | Secondary safety outcomes include the in-hospital diagnosis of stroke | Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days. | |
| Secondary | Venous thrombotic event - deep vein thrombosis | Secondary safety outcomes include the in-hospital diagnosis of deep vein thrombosis | Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days. | |
| Secondary | Venous thrombotic event - pulmonary embolus | Secondary safety outcomes include the in-hospital diagnosis of pulmonary embolus | Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days. | |
| Secondary | Length of hospitalization | Hospital length of stay | Length of index hospital admission | |
| Secondary | Intensive care unit (ICU) admission | Proportion of participants requiring ICU admission | Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days. | |
| Secondary | Hospital survival | Proportion of patients alive at hospital discharge | Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days. | |
| Secondary | 90 day survival | Survival at 90-days post-operative | Up to day 30 | |
| Secondary | Compliance | The proportion of enrolled patients who receive a minimum of one dose of the study intervention | Intraoperative | |
| Secondary | Clinical -a patient centered outcome | 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 | Up to day 30 postoperative |