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

Who is this study for? Patients Undergoing Major Non-cardiac Surgeries
What treatments are being studied? Tranexamic Acid (TXA)
Status: Active_not_recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ Hospital sites will be included in the trial if anesthesia 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.

Locations
Other Locations
Canada
Kingston Health Sciences Centre
Kingston
London Health Sciences Centre
London
Hôpital Montfort
Ottawa
Ottawa Hospital Research Institute- Civic and General sites
Ottawa
Health Sciences North Research Institute
Sudbury
Humber River Hospital
Toronto
Grace Hospital
Winnipeg
St. Boniface Hospital
Winnipeg
University of Manitoba- HSC Campus
Winnipeg
Time Frame
Start Date: 2022-02-16
Completion Date: 2024-10-31
Participants
Target number of participants: 8440
Treatments
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).
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).
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Health Sciences Centre Foundation, Manitoba, The Ottawa Hospital
Leads: University of Manitoba

This content was sourced from clinicaltrials.gov

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