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

NCT04803747 | Completed Phase 4 DMC

• 1 other identifier: TXA-51231
• Study Type: interventional
• Target: 8,421
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Major Non-cardiac Surgeries

Keywords

Tranexamic acid (TXA); Venous thromboembolism (VTE); Deep vein thrombosis (DVT); Transfusion; Perioperative Bleeding

Outcome Measures

Primary Outcomes (2)

• Proportion of patients transfused RBCs

  Proportion of patients requiring transfused RBCs

  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

  Within 90 days of surgery

Secondary Outcomes (11)

• 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.

• Arterial event - myocardial infarction

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

• Arterial event - stroke

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

• Venous thrombotic event - deep vein thrombosis

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

• Venous thrombotic event - pulmonary embolus

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

Study Arms (2)

Tranexamic acid (TXA) Arm

ACTIVE COMPARATOR

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).

Drug: Tranexamic acid (TXA)

Placebo Arm

PLACEBO COMPARATOR

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).

Drug: Placebo (0.9 % Saline)

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).

Tranexamic acid (TXA) Arm

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).

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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):
• 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)
• Orthopedics (hip fracture repair, pelvic fixation, femur repair / fixation, shoulder / humerus open reduction internal fixation, lower extremity amputation)
• Spine (vertebrectomy, surgery involving \>/= 3 levels)
• Otolaryngology (glossectomy, mandibulectomy, radical laryngectomy)
• Thoracic (lung resection or decortication)
• Vascular (arterial bypass / endarterectomy / aneurysmorrhaphy involving the aorta or proximal vessels off the aorta)
• Gynecology (hysterectomy)
• Urology (nephrectomy, cystectomy, prostatectomy, pelvic exenteration)
• Plastic surgery (large neoplasm resections, burns or debridements)
• Surgeries anticipated to be associated with 5% or greater risk of RBC transfusion in hospital as per the surgical team.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• The Ottawa Hospital: collaborator
• Health Sciences Centre Foundation, Manitoba: collaborator

Study Sites (10)

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

University of Manitoba- HSC Campus

Winnipeg, Manitoba, R3E 0W2, Canada

Location

Grace Hospital

Winnipeg, Manitoba, R3J 3M7, Canada

Location

Health Sciences North Research Institute

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Ottawa Hospital Research Institute- General Campus

Ottawa, Ontario, K1H8L6, Canada

Location

Hôpital Montfort

Ottawa, Ontario, K1K 0T2, Canada

Location

Ottawa Hospital Research Institute- Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

Humber River Hospital

Toronto, Ontario, M3M 0B2, Canada

Location

Related Publications (1)

• Houston BL, McIsaac DI, Breau RH, Andrews M, Avramescu S, Bagry H, Balshaw RF, Daya J, Duncan K, Harle C, Jacobsohn E, Kerelska T, McIsaac S, Ramsay T, Saha T, Perelman I, Recio A, Solvason D, Szoke D, Tenenbein M, Fergusson DA, Zarychanski R. Hospital policy of tranexamic acid to reduce transfusion in major non-cardiac surgery (TRACTION): protocol for a phase IV randomised controlled trial. BMJ Open. 2024 Jun 3;14(6):e084847. doi: 10.1136/bmjopen-2024-084847.

  PMID: 38830735 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ryan Zarychanski, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nominated Principal Investigator

Model Details: TRACTION is a pragmatic, multicenter, randomized, registry-based cluster-crossover trial.

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: March 18, 2021
• Study Start: February 16, 2022
• Primary Completion: March 5, 2024
• Study Completion: June 3, 2024
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)