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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
Must not have
Acute subdural hematoma with no chronic component
Known hereditary thrombophilia, including Factor V Leiden, Antithrombin III mutation, Protein C deficiency, Protein S deficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 32 weeks

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a recent brain bleed without any old bleeding.
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I have a genetic condition that increases my risk of blood clots.
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I have visible blood in my urine.
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I have atrial fibrillation but it's controlled with treatment.
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I have had a vascular stenting procedure in the past year.
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I have an active cancer diagnosis.
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I am currently on hormone therapy for cancer.
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I am currently taking birth control pills.
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I am currently taking blood thinner medication.
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I haven't had blood clots, stroke, or related issues in the past 6-12 months.
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I have had a blood clot in my veins or lungs without a known cause.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hematoma resolution
Secondary study objectives
Cognitive function
Complications
Functional autonomy
+4 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

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
~2740

Find a Location

Who is running the clinical trial?

Centre de recherche du Centre hospitalier universitaire de SherbrookeLead Sponsor
61 Previous Clinical Trials
33,384 Total Patients Enrolled
Université de SherbrookeOTHER
304 Previous Clinical Trials
76,599 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
~0 spots leftby Dec 2024
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