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

TXA-51231

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

2022-02-16

2024-03-05

2024-10-31

Active (not recruiting)

Early phase I

8440

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'TRACTION is a pragmatic, multicenter, randomized, registry-based cluster-crossover trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': "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. Intervention assignment will only be known to the research pharmacy staff who will prepare the study drug specific to the interval assignment. To minimize sources of selection and ascertainment biases, anesthesiologists, surgeons, investigators, research staff, and members of the Data Safety and Monitoring Board will all be blinded to randomization schemes and treatments administered; only the trial statistician will have access to randomization schemes for all sites. The research site's Pharmacy staff will not have contact with the study team or the patient and will be expressly forbidden to discuss individual treatment allocation with the study team, the patient, the operating room and clinical care team unless emergency un-blinding is warranted.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 8440, 'type': 'ACTUAL'}}

2024-05-16