Major Non-cardiac Surgeries
Conditions
Keywords
Tranexamic acid (TXA), Venous thromboembolism (VTE), Deep vein thrombosis (DVT), Transfusion, Perioperative Bleeding
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. 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.
Interventions
DRUGTranexamic 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 (0.9 % normal saline) 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).
Sponsors
University of Manitoba
Canadian Institutes of Health Research (CIHR)
Health Sciences Centre Foundation, Manitoba
The Ottawa Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
TRACTION is a pragmatic, multicenter, randomized, registry-based cluster-crossover trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Cluster-level inclusion criteria: Hospital sites will be included in the trial if the site performs ≥ 100 noncardiac surgeries per month, and if anesthesia, surgery 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 (i.e., arterial or venous thrombosis within 90 days preoperative) * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORRyan Zarychanski, MD
University of Manitoba
Outcome results
None listed