Preventing Recurrences of Chronic Subdural Hematoma in Adult Patients by Middle Meningeal Artery Embolization (MEMBRANE)

Unfallkrankenhaus Berlin

Status: Enrolling

Conditions: Hematoma, Subdural, Chronic

Treatments: Procedure: Surgery plus endovascular MMA embolization; Procedure: Surgery alone

Study type: Interventional

Funder types: Other

Identifiers

NCT05327933

DRKS00020465 (Other Identifier)

MMA_SP

Details and patient eligibility

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.

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. Age ≥18 years
3. Sufficient compliance and ability to consent
4. Patient's informed consent for surgical as well as endovascular interventional procedure and participation in the study

Exclusion criteria

1. Conservatively treated cSDH
2. Radiological evidence of an acute or subacute subdural hematoma, subarachnoid hemorrhage, intracerebral hematoma or epidural hematoma
3. Surgical technique: craniotomy, craniectomy, bilateral burr hole trepanation
4. Angiography cannot be performed within 72 hours after surgery
5. Age <18 years
6. Supervisory relationship
7. Pregnancy
8. Lack of informed consent
9. Lack of compliance
10. Homozygous factor XIII deficiency with residual activity <10%

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

154 participants in 2 patient groups

Surgery plus endovascular MMA embolization

Experimental group

Treatment:

Procedure: Surgery plus endovascular MMA embolization

Surgery alone

Active Comparator group

Treatment:

Procedure: Surgery alone