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

University of Manitoba

Status and phase: Completed; Phase 4

Conditions: Major Non-cardiac Surgeries

Treatments: Drug: Tranexamic acid (TXA); Drug: Placebo (0.9 % Saline)

Study type: Interventional

Funder types: Other

Identifiers

NCT04803747

TXA-51231

Details and patient eligibility

About

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

Full 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.

Enrollment: 8,421 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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8,421 participants in 2 patient groups, including a placebo group

Tranexamic acid (TXA) Arm

Active Comparator group

Description:

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).

Treatment:

Drug: Tranexamic acid (TXA)

Placebo Arm

Placebo Comparator group

Description:

Placebo 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).

Treatment:

Drug: Placebo (0.9 % Saline)