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

University of Manitoba8,421 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

8,421

Conditions

Major Non-cardiac Surgeries

Interventions

Tranexamic acid (TXA)DRUG

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 % Saline)DRUG

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

St. Boniface Hospital

Winnipeg, Manitoba, Canada

University of Manitoba- HSC Campus

Winnipeg, Manitoba, Canada

Grace Hospital

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

Proportion of patients transfused RBCs

Proportion of patients requiring transfused RBCs

Time frame: From date of surgery until the date of hospital discharge, assessed up to 90 days

Incidence of DVT or PE (collectively called venous thromboembolism (VTE)

Number of patients with VTE events

Time frame: Within 90 days of surgery

Secondary Outcomes

Transfused units

The number of RBC units transfused (both at hospital level and patient level).

Time frame: 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.

Arterial event - myocardial infarction

Secondary safety outcomes include the in-hospital diagnosis of myocardial infarction

Time frame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.

Arterial event - stroke

Secondary safety outcomes include the in-hospital diagnosis of stroke

Time frame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.

Venous thrombotic event - deep vein thrombosis

Secondary safety outcomes include the in-hospital diagnosis of deep vein thrombosis

Time frame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.

Venous thrombotic event - pulmonary embolus

Secondary safety outcomes include the in-hospital diagnosis of pulmonary embolus

Data from ClinicalTrials.gov

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