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Tranexamic Acid for Subdural Hematoma (TRACS Trial)

Phase 2 & 3
Recruiting
Led By David Mathieu, M.D.
Research Sponsored by Centre de recherche du Centre hospitalier universitaire de Sherbrooke
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 32 weeks
Awards & highlights

TRACS Trial Summary

This trial will investigate whether Tranexamic Acid (TXA) can help treat chronic subdural hematoma (CSDH), a common and debilitating condition for which there is no widely accepted medical treatment.

Who is the study for?
This trial is for patients recently diagnosed (within the last 14 days) with chronic subdural hematoma. It's not suitable for those with acute hematomas, thrombotic diseases, recent strokes or heart surgeries, active cancer treatments, certain genetic disorders related to blood clotting, or women who are pregnant/breastfeeding.Check my eligibility
What is being tested?
The study tests if Tranexamic Acid can help resolve chronic subdural hematomas without surgery and prevent recurrence after surgical treatment. Participants will receive either TXA or a placebo alongside standard care in this double-blind phase IIB trial.See study design
What are the potential side effects?
Tranexamic Acid may cause side effects such as nausea, diarrhea, vomiting; it could also increase the risk of blood clots in individuals predisposed to thromboembolic events.

TRACS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~32 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 32 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hematoma resolution
Secondary outcome measures
Cognitive function
Complications
Functional autonomy
+7 more

Side effects data

From 2015 Phase 4 trial • 29 Patients • NCT02063035
8%
Postoperative wound infection
8%
Postoperative wound infection after release from hospital
8%
Myocardial infaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Tranexamic Acid

TRACS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tranexamic acidExperimental Treatment1 Intervention
Tranexamic acid 750 mg daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablet daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic Acid
2011
Completed Phase 4
~3930

Find a Location

Who is running the clinical trial?

Centre de recherche du Centre hospitalier universitaire de SherbrookeLead Sponsor
58 Previous Clinical Trials
31,035 Total Patients Enrolled
Université de SherbrookeOTHER
290 Previous Clinical Trials
68,815 Total Patients Enrolled
David Mathieu, M.D.Principal InvestigatorUniversité de Sherbrooke

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT02568124 — Phase 2 & 3
Subdural Hematoma Research Study Groups: Tranexamic acid, Placebo
Subdural Hematoma Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT02568124 — Phase 2 & 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT02568124 — Phase 2 & 3

Frequently Asked Questions

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

Are there any available openings for volunteers in this experiment?

"The research indicates that this clinical trial is actively recruiting patients. The original posting date was November 1st, 2015, with the most recent edit on November 8th, 2021."

Answered by AI

To what end does Tranexamic Acid typically provide relief?

"Tranexamic Acid can be used to effectively manage hyperfibrinolysis, hemophilia, and bleeding."

Answered by AI

Could you please share any other case studies that have used Tranexamic Acid?

"There are currently 69 clinical trials ongoing for Tranexamic Acid, with 29 of them in Phase 3. Out of the 305 total locations hosting trials for this medication, many of them are based in Kansas City, Kansas."

Answered by AI
~10 spots leftby Dec 2024