Using Tranexamic Acid to Treat Chronic Subdural Hematomas

Tranexamic Acid in Chronic Subdural Hematomas

This study is testing if Tranexamic Acid can help patients with chronic subdural hematomas heal better and reduce the chances of needing surgery again.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke (Academic / other)
• Locations: 3 sites (Edmonton, Alberta and 2 other locations)
• Trial ID: NCT02568124 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Tranexamic Acid (TXA) in promoting the resolution of chronic subdural hematomas (CSDH) in patients who have recently been diagnosed. It is a double-blind, randomized, placebo-controlled study designed to assess the feasibility, safety, and preliminary efficacy of TXA compared to a placebo. The trial aims to determine if TXA can reduce the need for surgical interventions and lower the recurrence rates of CSDH after surgical evacuation. Eligible patients will be screened at the Centre Hospitalier Universitaire de Sherbrooke and other participating locations.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with chronic subdural hematomas within the last 14 days who do not have contraindications to Tranexamic Acid.

Not a fit: Patients with acute subdural hematomas, active thromboembolic diseases, or other specific risk factors will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-surgical option for patients with chronic subdural hematomas, potentially reducing the need for surgery and improving patient outcomes.

How similar studies have performed: While there is limited data on the use of TXA for chronic subdural hematomas, similar studies in other conditions have shown promising results, making this approach potentially novel.

Eligibility criteria

Inclusion Criteria:

* CT scan demonstrating the existence of a subdural hematoma containing a chronic component
* Diagnosis within the last 14 days

Exclusion Criteria:

* Acute subdural hematoma with no chronic component;
* Active thrombotic, thromboembolic or atheroembolic disease, including deep venous thrombosis within the last six months, cerebral thrombosis within the last six months, symptomatic carotid stenosis who did not undergo surgery or stroke within the last year;
* Past history of unprovoked deep venous thrombosis or idiopathic pulmonary embolism;
* Known hereditary thrombophilia, including Factor V Leiden, Antithrombin III mutation, Protein C deficiency, Protein S deficiency;
* Atrial fibrillation (unless under successful rhythm control therapy);
* Metallic heart valve;
* Vascular stenting procedure within the last year;
* Cardiac or vascular surgical procedure within the last 6 months, including endarterectomy, bypass or angioplasty;
* Ongoing investigation for suspected malignancy;
* Confirmed active malignancy;
* Concomitant hormone therapy for malignancy;
* Concomitant hormone contraceptive pill;
* Macroscopic hematuria;
* Known or suspected tranexamic acid allergy;
* Pregnancy or breastfeeding;
* Concomitant use of anticoagulant medication;
* Any concern from the attending physician.

Where this trial is running

Edmonton, Alberta and 2 other locations

• University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
• Centre Hospitalier Universitaire de Sherbrooke — Sherbrooke, Quebec, Canada (Recruiting)
• Centre Hospitalier Affilié Universitaire de Québec — Québec, Canada (Recruiting)

Study contacts

• Principal investigator: David Mathieu, M.D. — Université de Sherbrooke
• Study coordinator: David Mathieu, M.D.

Conditions Chronic Subdural Hematoma; Tranexamic acid; Cyklokapron; Conservative management; Medical management