Status:
RECRUITING
Preventing Recurrences of Chronic Subdural Hematoma in Adult Patients by Middle Meningeal Artery Embolization
Lead Sponsor:
Unfallkrankenhaus Berlin
Conditions:
Hematoma, Subdural, Chronic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients with a chronic subdural hematoma (cSDH), that is, a blood accumulation between two meninges developing over a long period of time, often have recurrent bleedings after an initial operation. T...
Eligibility Criteria
Inclusion
- Patients who have undergone surgery by means of one or more burr hole trepanations during the first manifestation of a cSDH (unihemispherical or bihemispherical) detected by computed tomography or magnetic resonance tomography
- Age ≥18 years
- Sufficient compliance and ability to consent
- Patient's informed consent for surgical as well as endovascular interventional procedure and participation in the study
Exclusion
- Conservatively treated cSDH
- Radiological evidence of an acute or subacute subdural hematoma, subarachnoid hemorrhage, intracerebral hematoma or epidural hematoma
- Surgical technique: craniotomy, craniectomy, bilateral burr hole trepanation
- Angiography cannot be performed within 72 hours after surgery
- Age \<18 years
- Supervisory relationship
- Pregnancy
- Lack of informed consent
- Lack of compliance
- Homozygous factor XIII deficiency with residual activity \<10%
Key Trial Info
Start Date :
May 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT05327933
Start Date
May 26 2022
End Date
October 1 2025
Last Update
March 30 2025
Active Locations (1)
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1
Unfallkrankenhaus Berlin
Berlin, State of Berlin, Germany, 12683