Tranexamic Acid for Major Non-Cardiac Surgery
(TRACTION Trial)

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen ByRyan Zarychanski, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Manitoba

Prior Safety Data

Trial Summary

What is the purpose of this trial?A Phase IV trial of a hospital policy of Tranexamic acid to reduce transfusion in major non-cardiac surgery.

Eligibility Criteria

Adults (18+) undergoing major non-cardiac surgery with a high risk of needing blood transfusions can join. Surgeries include extensive procedures in general, orthopedic, gynecology, plastic, vascular surgeries and more. Hospitals must follow the trial's policy. Pregnant individuals or those with recent trauma surgery using TXA, active blood clots or certain standard-of-care surgeries are excluded.

Inclusion Criteria

I have had surgery for a bone injury or amputation in my hip, pelvis, femur, shoulder, or leg.

I have had surgery on my lung.

I am 18 or older and will have a major surgery that is not heart-related.

+11 more

Exclusion Criteria

I received TXA for a trauma surgery within the last 3 hours.

Pregnancy

I am on blood thinners for a clotting disorder before joining the study.

+2 more

Participant Groups

This Phase IV trial tests if Tranexamic acid (TXA) reduces the need for blood transfusions during major non-cardiac surgeries compared to a saline placebo. Patients will be randomly given either TXA or placebo to see which is better at reducing transfusion rates.

2Treatment groups

Active Control

Placebo Group

Group I: Tranexamic acid (TXA) ArmActive Control1 Intervention

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).

Group II: Placebo ArmPlacebo Group1 Intervention

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).