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

Phase 4
Recruiting
Led By Ryan Zarychanski, MD
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 3 months of surgery.
Awards & highlights

TRACTION Trial Summary

This trial looks at whether using Tranexamic acid can help reduce the amount of blood transfusions needed during major non-cardiac surgery.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Tranexamic acid may cause side effects like nausea, vomiting, diarrhea, dizziness or signs of an allergic reaction such as rash or itching. It could also increase the risk of blood clots.

TRACTION Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older and will have a major surgery that is not heart-related.
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My surgery is expected to last 3+ hours or has a high risk of needing a blood transfusion.
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I have had surgery that might qualify me for this trial.
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I have had major abdominal surgery.
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I have had surgery for a bone injury or amputation in my hip, pelvis, femur, shoulder, or leg.
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I have had major spine surgery.
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I have had surgery to remove part of my tongue, jaw, or voice box.
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I have had surgery on my lung.
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I have had surgery on the large arteries near my heart.
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I have had a hysterectomy.
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I have had surgery on my kidneys, bladder, prostate, or pelvic area.
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I have had plastic surgery for large tumor removal, burns, or wound cleaning.
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My upcoming surgery has a high risk of needing a blood transfusion.

TRACTION Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 3 months of surgery.
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 3 months of surgery. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of DVT or PE (collectively called venous thromboembolism (VTE)
Proportion of RBC Transfusions
Secondary outcome measures
Arterial or Venous thrombotic events
Clinical
Compliance
+2 more

TRACTION Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Tranexamic acid (TXAl 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).

Find a Location

Who is running the clinical trial?

The Ottawa HospitalOTHER
92 Previous Clinical Trials
54,168 Total Patients Enrolled
University of ManitobaLead Sponsor
592 Previous Clinical Trials
191,050 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,333 Previous Clinical Trials
25,739,038 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04803747 — Phase 4
Noncardiac Surgery Research Study Groups: Tranexamic acid (TXAl Arm, Placebo Arm
Noncardiac Surgery Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04803747 — Phase 4
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04803747 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what magnitude is the participant population involved in this research?

"Affirmative. The clinical trial portal indicates that this medical investigation, initially posted on February 16th 2022, is currently recruiting participants. Approximately 8320 individuals must be sourced from 3 distinct healthcare sites."

Answered by AI

For what maladies is Tranexamic acid (TXAl Arm utilized?

"Hyperfibrinolysis is commonly treated with Tranexamic acid (TXAl Arm, which can also be used to help manage hemophilia, bleeding disorders and the post-operative blood loss from tooth extractions."

Answered by AI

Are there any potential adverse effects of utilizing Tranexamic acid (TXA) for patients?

"Leveraging clinical data and safety trials, our assessment at Power gave Tranexamic acid (TXAl Arm) a score of 3 as it is approved for medical use."

Answered by AI

Has there been any previous research regarding the efficacy of Tranexamic acid (TXA) for treatment?

"Tranexamic acid was initially investigated in 2010 by the First Affiliated Hospital of Guangzhou TCM University and there have since been 216 completed trials. In 2021, 61 studies are currently ongoing, with much of this research taking place in Winnipeg, Manitoba."

Answered by AI

Are there any opportunities to enroll in this experiment at present?

"Indeed, according to the clinicaltrials.gov website, this research trial is actively recruiting subjects. It was first posted on February 16th 2022 and underwent its most recent update on April 5th of that year. The study requires 8320 participants across 3 distinct sites."

Answered by AI

What outcomes is this experiment aiming to produce?

"The primary goal of this experiment is to determine the proportion of RBC transfusions over a 3 month window. Secondary objectives include establishing how many units were transfused, if any arterial/venous thrombotic events occurred, and quantifying the days at home up until day 30 (DAH30)."

Answered by AI
~2698 spots leftby Mar 2025