Clinical trial NCT04803747: A Trial of a Hospital Policy of Tranexamic Acid Use to Reduce Transfusion in Major Non-cardiac Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Major Non-cardiac Surgeries
Keywords: Tranexamic acid (TXA)
Venous thromboembolism (VTE)
Deep vein thrombosis (DVT)
Transfusion
Perioperative Bleeding
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Health Sciences Centre Foundation, Manitoba
name: The Ottawa Hospital
First posted: 2021-03-18
Enrollment: 8440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: TRACTION is a pragmatic, multicenter, randomized, registry-based cluster-crossover trial.
Primary purpose: TREATMENT

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 for a total of 8 months. 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.

Eligibility 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 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.

Primary outcomes:
measure: Proportion of patients transfused RBCs
timeFrame: From date of surgery until the date of hospital discharge, assessed up to 90 days
measure: Incidence of DVT or PE (collectively called venous thromboembolism (VTE)
timeFrame: Within 90 days of surgery
Secondary outcomes:
measure: Transfused units
timeFrame: 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.
measure: Arterial event - myocardial infarction
timeFrame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.
measure: Arterial event - stroke
timeFrame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.
measure: Venous thrombotic event - deep vein thrombosis
timeFrame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.
measure: Venous thrombotic event - pulmonary embolus
timeFrame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.
measure: Length of hospitalization
timeFrame: Length of index hospital admission
measure: Intensive care unit (ICU) admission
timeFrame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.
measure: Hospital survival
timeFrame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.
measure: 90 day survival
timeFrame: Up to day 30
measure: Compliance
timeFrame: Intraoperative
measure: Clinical -a patient centered outcome
timeFrame: Up to day 30 postoperative
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: University of Manitoba- HSC Campus
state: Manitoba
city: Winnipeg
country: Canada
facility: Grace Hospital
state: Manitoba
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute- Civic and General sites
state: Ontario
city: Ottawa
country: Canada
facility: Hôpital Montfort
state: Ontario
city: Sudbury
country: Canada
facility: Health Sciences North Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Humber River Hospital
state: Ontario
Study officials:
affiliation: University of Manitoba
name: Ryan Zarychanski, MD
role: PRINCIPAL_INVESTIGATOR
References: