Using tranexamic acid to reduce bleeding during brain tumor surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of tranexamic acid (TXA) on reducing blood loss in patients undergoing craniotomy for brain tumor resection. Participants will be randomly assigned to receive either TXA or a placebo, with the TXA administered as a bolus followed by an infusion during surgery. The study aims to determine if TXA can decrease estimated blood loss and prevent complications related to bleeding, such as the need for re-operation or mortality. The trial will also monitor for any potential side effects of TXA during the procedure.

Why it matters

Who can join: the full rules

Inclusion Criteria are the following:

1. Adult male or female, between 18-80 years of age.
2. Patients are scheduled to undergo a craniotomy for tumor resection.
3. Patients/ Substitute Decision Maker have given written consent to participate.

Exclusion Criteria are the following: Patients who meet any of the following exclusion criteria will not be eligible.

1. Patients with known active or previous history of thromboembolic disease or deep venous thrombosis.
2. Patients with known pre-existing coagulopathy such as hemophilia, Von Willebrand disease, and clotting factor deficiencies.
3. Patients with renal impairment and eGFR \<60 ml/min/1.73 m2 as determined by the lab or calculated by using the Cockcroft Gault formula or end stage renal disease currently on dialysis.
4. Female subjects who are pregnant or currently breastfeeding.
5. Patients with Class 3 (high-risk) obesity BMI ≥ to 40.
6. Patients undergoing emergency craniotomy or mini craniotomy or craniectomies.
7. Patients who received embolization prior to surgery.

Where it's running

• Nova Scotia Health Authority- Queen Elizabeth II Health Sciences Center
  Halifax, Nova Scotia, Canada Recruiting

Study contacts

• Principal investigator: Stephen Lownie, MD — Nova Scotia Health Authority- Queen Elizabeth II HSC
• Study coordinator: Stephen Lownie, MD
• Email: stephen.lownie@nshealth.ca
• Phone: 902-473-6449

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.