Overview

The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies

Status:
RECRUITING
Trial end date:
2027-12-31
Target enrollment:
Participant gender:
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.
Phase:
PHASE3
Details
Lead Sponsor:
Stephen Lownie
Collaborator:
Dalhousie University
Treatments:
Injections, Intravenous
Saline Solution
Sodium Chloride
Solutions
Tranexamic Acid