Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Unfallkrankenhaus Berlin
RECRUITING
Berlin
Contact Information
Primary
Johannes Lemcke, PD Dr. med.
johannes.lemcke@ukb.de
00493056813701
Backup
Leonie Goelz, Dr. med.
leonie.goelz@ukb.de
Time Frame
Start Date: 2022-05-26
Estimated Completion Date: 2025-10
Participants
Target number of participants: 154
Treatments
Experimental: Surgery plus endovascular MMA embolization
Active_comparator: Surgery alone
Sponsors
Leads: Unfallkrankenhaus Berlin

This content was sourced from clinicaltrials.gov