Actively Recruiting
The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies
Led by Stephen Lownie · Updated on 2026-03-19
102
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
Sponsors
S
Stephen Lownie
Lead Sponsor
D
Dalhousie University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male or female, between 18-80 years of age
- Scheduled to undergo craniotomy for tumor removal
- Provided written consent to participate or substitute decision maker consented
You will not qualify if you...
- History of blood clots or thromboembolic disease
- Known bleeding disorders such as hemophilia or clotting factor deficiencies
- Kidney impairment with eGFR less than 60 ml/min/1.73 m2 or on dialysis
- Pregnant or breastfeeding females
- High-risk obesity with BMI of 40 or higher
- Undergoing emergency craniotomy, mini craniotomy, or craniectomy
- Received embolization before surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nova Scotia Health Authority- Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H3A7
Actively Recruiting
Research Team
S
Stephen Lownie, MD
CONTACT
L
Lisa Julien, RN BScN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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