Adjuvant Tranexamic Acid (TXA) Versus Surgery Alone for Adult Patients With Chronic Subdural Hematoma (CSDH)
Recruiting
Phase 2
Phase 3
Interventional Study
Chronic Subdural Hematoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 274 (estimated)
- Sponsor
- St. Olavs Hospital · Other
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About This Trial
This study is an open label randomized controlled trial. Patients with a symptomatic Chronic Subdural Hematoma (CSDH) confirmed on radiological imaging, planned for surgery, age over 18, free from other intracranial pathologies and no previous intracranial surgery, will be recruited at time of admission. Patients eligible for inclusion will be randomized to receive treatment with Tranexamic acid (…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Symptomatic chronic subdural hematoma confirmed on computer tomography (CT) or magnetic resonance imaging (MRI) measuring greater than 10 mm thickness.
2. Adult patient ≥18 years
3. Scheduled for single or double burr hole for evacuation.
4. No contraindication for TXA
Exclu…
Contacts