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The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies

RecruitingPhase 3Ages 18 Years - 80 YearsAllStephen Lownie
NCT06229483 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 b

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📋 Eligibility rules (as published)
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.
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What it tests

  • TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION
  • Placebo
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Where

1 site
Nova Scotia Health Authority- Queen Elizabeth II Health Sciences Center
Halifax, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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