Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT06229483

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies | DecenTrialz