The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The goal of this clinical trial is to test the effect of a drug called tranexamic acid (TXA) on reducing blood loss in participants undergoing surgery to remove brain tumors. The main questions it aims to answer are: 1. Does TXA 20 mg/kg IV bolus of TXA, and 1 mg/kg/hr infusion of TXA reduce the amount of estimated blood loss during surgery? 2. Does TXA 20 mg/kg IV bolus of TXA, and 1 mg/kg/hr infusion of TXA prevent re-operation, disability or death related to bleeding inside the head during and after surgery? Participants are randomized to receive 20 mg/kg IV bolus of TXA or matching placebo within 30 minutes of start of surger, and then 1 mg/kg/hr infusion of TXA or matching from the start of surgery to end of surgery. Treatment allocation is blinded. Investigator will compare the two treatment arms to see whether there are differences in the amount of blood loss during surgery and bleeding-related complications. Investigators will also monitor for any side effects of TXA.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• Adult male or female, between 18-80 years of age.

• Patients are scheduled to undergo a craniotomy for tumor resection.

• Patients/ Substitute Decision Maker have given written consent to participate.

Locations
Other Locations
Canada
Nova Scotia Health Authority- Queen Elizabeth II Health Sciences Center
RECRUITING
Halifax
Contact Information
Primary
Stephen Lownie, MD
stephen.lownie@nshealth.ca
902-473-6449
Backup
Lisa Julien, RN BScN
lisa.julien@nshealth.ca
902-473-3877
Time Frame
Start Date: 2024-04-03
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 102
Treatments
Experimental: Tranexamic Acid
Participants will be randomized in a 1:1 ratio to receive tranexamic acid 20 mg/kg IV bolus or identical volume of placebo 0.9 % NaCl within 30 minutes prior to the skin incision followed by a 1 mg/kg/hr infusion of TXA, or identical volume of placebo 0.9 % NaCl, for the duration of surgery. Treatment is blinded.
Placebo_comparator: Matching Placebo
Participants will be randomized in a 1:1 ratio to receive tranexamic acid 20 mg/kg IV bolus or identical volume of placebo 0.9 % NaCl within 30 minutes prior to the skin incision followed by a 1 mg/kg/hr infusion of TXA, or identical volume of placebo 0.9 % NaCl, for the duration of surgery. Treatment is blinded.
Related Therapeutic Areas
Sponsors
Collaborators: Dalhousie University
Leads: Stephen Lownie

This content was sourced from clinicaltrials.gov