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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
Diagnosis of chronic subdural hematoma (CSDH)
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 Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with chronic subdural hematoma (CSDH).

TRACE-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 4, 8, and 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4, 8, and 12 weeks for reporting.

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 more

TRACE-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
536 Previous Clinical Trials
447,439 Total Patients Enrolled
The Physicians' Services Incorporated FoundationOTHER
162 Previous Clinical Trials
26,665 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

Subdural Hematoma Research Study Groups: Placebo Control Arm, Tranexamic Acid Arm

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical indications warrant the consumption of Tranexamic Acid 500 MG?

"Tranexamic Acid 500 MG is utilized to reduce the destruction of fibrin, and can also be prescribed for hemophilia, dental extractions, or other forms of bleeding."

Answered by AI

Has the FDA granted approval for Tranexamic Acid 500 MG?

"The safety score of Tranexamic Acid 500 MG was assessed as a 2, since there is some evidence validating its security but no proof demonstrating efficacy."

Answered by AI

Are there any participants needed for this research endeavor?

"As documented on clinicaltrials.gov, the original posting of this trial was recorded as July 1st 2021 and has not been recently updated since May 18th 2021; thus, it is presently not looking for participants. However, there are 120 other studies that have open recruitment positions available at present."

Answered by AI

How many individuals are being selected to participate in this research endeavor?

"The search for participants in this particular trial has concluded, as the last edit to its profile was made on May 18th 2021. If you are seeking out alternative trials, there are currently 59 clinical studies recruiting patients with hematoma and subdural issues and 61 related to Tranexamic Acid 500 MG."

Answered by AI

Have there been any prior tests of Tranexamic Acid 500 MG's efficacy?

"Presently, there are a total of 61 active clinical trials dealing with the effects and efficacy of Tranexamic Acid 500 MG. Among these clinical studies, 26 have made it to Phase 3. While most research is conducted in Kansas City, Kansas; other 185 sites across different countries are also collecting data for this medication's usage."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma -2
2021. "Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma -2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04898712.
~24 spots leftby Apr 2025
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