The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies
Recruiting
Phase 3
Interventional Study
Brain Tumor
Bleeding
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 102 (estimated)
- Sponsor
- Stephen Lownie · Other
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About This Trial
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 in…
Trial Locations
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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 mee…
Contacts