RecruitingPhase 3NCT06229483

The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies

Sponsor

Stephen Lownie

Enrollment

102 participants

Start Date

Apr 3, 2024

Study Type

INTERVENTIONAL

Conditions

Brain Tumor Bleeding

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether giving a medication called tranexamic acid (which helps blood clot) during brain surgery (craniotomy) for tumor removal reduces bleeding and improves outcomes. **You may be eligible if...** - You are between 18 and 80 years old - You are scheduled to have a craniotomy (open brain surgery) to remove a tumor - You or your substitute decision-maker has provided written consent **You may NOT be eligible if...** - You have a history of blood clots, deep vein thrombosis, or clotting disorders (such as hemophilia or Von Willebrand disease) - You have kidney impairment (eGFR below 60 or on dialysis) - You are female and pregnant or have given birth recently - You have conditions that would make tranexamic acid unsafe for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION

Tranexamic acid 20 mg/kg IV bolus within 30 minutes prior to the skin incision followed by a 1 mg/kg/hr infusion of TXA, for the duration of surgery. Treatment is blinded.

OTHERPlacebo

0.9% normal saline 20ml/kg IV bolus within 30 minutes prior to the skin incision followed by a 1 ml/kg/hr infusion of 0.9 % sodium chloride for the duration of surgery. Treatment is blinded.

Locations(1)

Nova Scotia Health Authority- Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, Canada

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NCT06229483

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