NCT06229483 The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies
| NCT ID | NCT06229483 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Stephen Lownie |
| Condition | Brain Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2024-04-03 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 102 participants in total. It began in 2024-04-03 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Stephen Lownie, MD
PRINCIPAL INVESTIGATOR
Nova Scotia Health Authority- Queen Elizabeth II HSC
Frequently Asked Questions
Who can join the NCT06229483 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Brain Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06229483 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 102 participants.
Is NCT06229483 currently recruiting?
Yes, NCT06229483 is actively recruiting participants. Contact the research team at stephen.lownie@nshealth.ca for enrollment information.
Where is the NCT06229483 trial being conducted?
This trial is being conducted at Halifax, Canada.
Who is sponsoring the NCT06229483 clinical trial?
NCT06229483 is sponsored by Stephen Lownie. The principal investigator is Stephen Lownie, MD at Nova Scotia Health Authority- Queen Elizabeth II HSC. The trial plans to enroll 102 participants.