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

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

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

Study Overview

• Status: Completed
• Conditions: Major Non-cardiac Surgeries
• Intervention / Treatment: Drug: Tranexamic acid (TXA); Drug: Placebo (0.9 % Saline)

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.

• Study Type: Interventional
• Enrollment (Actual): 8421
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3J 3M7
      • Grace Hospital
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface Hospital
    • Winnipeg, Manitoba, Canada, R3E 0W2
      • University of Manitoba- HSC Campus
  • Ontario
    • Greater Sudbury, Ontario, Canada, P3E 5J1
      • Health Sciences North Research Institute
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston Health Sciences Centre
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre
    • Ottawa, Ontario, Canada, K1K 0T2
      • Hôpital Montfort
    • Ottawa, Ontario, Canada, K1H8L6
      • Ottawa Hospital Research Institute- General Campus
    • Ottawa, Ontario, Canada, K1Y 4E9
      • Ottawa Hospital Research Institute- Civic Campus
    • Toronto, Ontario, Canada, M3M 0B2
      • Humber River Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Arm; 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); 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).
Active Comparator: Tranexamic acid (TXA) Arm; 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); 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfused units	The number of RBC units transfused (both at hospital level and patient level).	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	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	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	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	Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.
Length of hospitalization	Hospital length of stay	Length of index hospital admission
Intensive care unit (ICU) admission	Proportion of participants requiring ICU admission	Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.
Hospital survival	Proportion of patients alive at hospital discharge	Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.
90 day survival	Survival at 90-days post-operative	Up to day 30
Compliance	The proportion of enrolled patients who receive a minimum of one dose of the study intervention	Intraoperative
Clinical -a patient centered outcome	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	Up to day 30 postoperative

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Canadian Institutes of Health Research (CIHR); Health Sciences Centre Foundation, Manitoba; The Ottawa Hospital
• Investigators: Principal Investigator: Ryan Zarychanski, MD, University of Manitoba

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2022
• Primary Completion (Actual): March 5, 2024
• Study Completion (Actual): June 3, 2024

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Transfusion; Deep vein thrombosis (DVT); Tranexamic acid (TXA); Venous thromboembolism (VTE); Perioperative Bleeding
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thromboembolism; Thrombosis; Venous Thrombosis; Venous Thromboembolism; Organic Chemicals; Carboxylic Acids; Inorganic Chemicals; Chlorine Compounds; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Sodium Compounds; Chlorides; Hydrochloric Acid; Tranexamic Acid; Sodium Chloride
• Other Study ID Numbers: TXA-51231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to share individual participant data to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No