Actively Recruiting
Preventing Recurrences of Chronic Subdural Hematoma in Adult Patients by Middle Meningeal Artery Embolization
Led by Unfallkrankenhaus Berlin · Updated on 2025-03-30
154
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. The study aims to show that additional surgery reduces the risk of recurrent bleeding. The additional procedure aims to block small blood vessels in the skull with tiny plastic particles. The small blood vessels are embolized using X-rays and a contrast medium and a fine tube that is inserted into the diseased vessels of the head via the groin. Patients of full age who have undergone burr hole trepanation as a first operation, i.e. a blood drain through a hole in the cranial cavity, can participate in the study. Participating patients are randomly assigned to a control group with treatment according to clinical routine or a treatment group with an additional occlusion of the blood vessels in the skull. In addition, patients can consent to a genetic test to determine the relationship between a coagulation factor and the risk of recurrence of the hematoma. In order to record the test results, check-up examinations are carried out after one and three months.
CONDITIONS
Official Title
Preventing Recurrences of Chronic Subdural Hematoma in Adult Patients by Middle Meningeal Artery Embolization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have undergone surgery by means of one or more burr hole trepanations during the first manifestation of a chronic subdural hematoma detected by CT or MRI
- Age 18 years or older
- Sufficient compliance and ability to consent
- Patient's informed consent for surgical and endovascular procedures and participation in the study
You will not qualify if you...
- Conservatively treated chronic subdural hematoma
- Radiological evidence of acute or subacute subdural hematoma, subarachnoid hemorrhage, intracerebral hematoma, or epidural hematoma
- Surgical techniques such as craniotomy, craniectomy, or bilateral burr hole trepanation
- Angiography cannot be performed within 72 hours after surgery
- Age under 18 years
- Supervisory relationship
- Pregnancy
- Lack of informed consent
- Lack of compliance
- Homozygous factor XIII deficiency with residual activity less than 10%
AI-Screening
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Trial Site Locations
Total: 1 location
1
Unfallkrankenhaus Berlin
Berlin, State of Berlin, Germany, 12683
Actively Recruiting
Research Team
J
Johannes Lemcke, PD Dr. med.
CONTACT
L
Leonie Goelz, Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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