Using tranexamic acid to reduce bleeding during brain tumor surgery

The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies

This study is testing if giving tranexamic acid during brain tumor surgery can help reduce bleeding and improve safety for patients.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Nova Scotia Health Authority (Academic / other)
• Locations: 1 site (Halifax, Nova Scotia)
• Trial ID: NCT06229483 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 scheduled for craniotomy to remove a brain tumor.

Not a fit: Patients with a history of thromboembolic disease, coagulopathy, or severe renal impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce blood loss and improve surgical outcomes for patients undergoing brain tumor surgery.

How similar studies have performed: Previous studies in other surgical fields have shown that TXA can effectively reduce bleeding, suggesting potential success in this novel application for neurosurgery.

Eligibility criteria

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 this trial is running

Halifax, Nova Scotia

• 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

Conditions Brain Tumor; Bleeding