Treatment for Major Non-cardiac Surgeries

Phase-Based Estimates
3
Effectiveness
3
Safety
University of Manitoba- HSC Campus, Winnipeg, Canada
Eligibility
18+
All Sexes
Eligible conditions
Major Non-cardiac Surgeries

Study Summary

This study is evaluating whether a policy of Tranexamic acid to reduce transfusion in major non-cardiac surgery is effective.

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Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes and 5 secondary outcomes in patients with Major Non-cardiac Surgeries. Measurement will happen over the course of Randomization through hospital discharge, anticipated less than 7 days..

Day 90
Clinical
Day 7
Arterial or Venous thrombotic events
Compliance
Proportion of RBC Transfusions
Transfused units
Month 3
Incidence of DVT or PE (collectively called venous thromboembolism (VTE)
up to day 30
the number of days at home to day 30 (DAH30)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Tranexamic acid (TXAl Arm
Placebo group

This trial requires 8320 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Tranexamic acid (TXAl Arm
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).
Placebo Arm
Drug
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).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within 3 months of surgery.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly within 3 months of surgery. for reporting.

Who is running the study

Principal Investigator
D. R. Z.
Dr. Ryan Zarychanski, MD
University of Manitoba

Closest Location

University of Manitoba- HSC Campus - Winnipeg, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients will be managed according to the policy being implemented and evaluated in the trial. show original
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
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)
Spine (vertebrectomy, surgery involving >/= 3 levels)
Otolaryngology (glossectomy, mandibulectomy, radical laryngectomy)
Vascular (arterial bypass / endarterectomy / aneurysmorrhaphy involving the aorta or proximal vessels off the aorta)
Gynecology (hysterectomy)
You have a hip fracture, pelvic fixation, femur fracture, lower extremity amputation, or shoulder fracture. show original
You have undergone a thoracic (lung resection or decortication) procedure. show original

Patient Q&A Section

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Major Non-cardiac Surgeries by sharing your contact details with the study coordinator.