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Tranexamic Acid for Subdural Hematoma (TRACE-2 Trial)
Phase 2
Waitlist Available
Led By Michael D Cusimano, MD, PhD
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 4, 8, and 12 weeks
Awards & highlights
TRACE-2 Trial Summary
This trial is testing whether the drug Tranexamic acid can reduce the volume of chronic subdural hematomas, which are collections of blood in the space between the brain and the skull that can cause severe neurological problems. The trial is designed as a double-blinded randomized controlled trial, which means that half of the patients will be given the drug and half will be given a placebo, and neither the patients nor the doctors will know who is receiving which. The primary endpoint is the change in volume of the hematoma after 4-8 weeks of treatment, and secondary endpoints include the hematoma volume at 8-12 weeks
Eligible Conditions
- Subdural Hematoma
TRACE-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 4, 8, and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 4, 8, and 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
36-Item Short Form Survey (SF-36)
Chronic subdural hematoma volume change
Markwalder's grading scale (MGS)
+5 moreTRACE-2 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tranexamic Acid ArmExperimental Treatment1 Intervention
Participants in the experimental arm will receive tranexamic acid (TXA) during surgery for CSDH evacuation with a single 1000mg intraoperative intravenous (IV) dose. Participants with a body weight 60-100kg will also receive a post-operative dose regimen of 500 mg TXA orally, 3 times a day (TID).
Weight deviations from this body weight range will be considered with a dose adjustment of 1000mg TXA two times a day (BID) for a body weight >100 kg, and 500 mg TXA BID for body weight <60kg.
Group II: Placebo Control ArmPlacebo Group1 Intervention
Participants in the control arm will placebo according to the same administration regimen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
FDA approved
Find a Location
Who is running the clinical trial?
Unity Health TorontoLead Sponsor
545 Previous Clinical Trials
450,382 Total Patients Enrolled
The Physicians' Services Incorporated FoundationOTHER
163 Previous Clinical Trials
28,337 Total Patients Enrolled
Michael D Cusimano, MD, PhDPrincipal InvestigatorSt. Michael's Hospital / University of Toronto
1 Previous Clinical Trials
130 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Control Arm
- Group 2: Tranexamic Acid Arm
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