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

NCT ID: NCT05327933

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-26
• Study Completion Date: 2025-10-31

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. 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

Hematoma, Subdural, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Surgery plus endovascular MMA embolization

Group Type: EXPERIMENTAL

Surgery plus endovascular MMA embolization

Intervention Type: PROCEDURE

A micro catheter is inserted transfemorally into the branches of the middle meningeal artery (MMA) in a minimally invasive manner and the periphery is occluded using polyvinyl alcohol (PVA) particles to prevent future bleeding. If the desired catheter position cannot be achieved due to the anatomical conditions, a more proximal closure of the MMA using Onyx® or micro-electric coils is performed. Embolization of the MMA by PVA particles with sizes between 40-300 µm is preferred over embolization by coils and Onyx®, since the capillary network of the dura is entirely blocked when using particles. In order to identify the vessels to be closed, a digital subtraction angiography (DSA) is performed.

Surgery alone

Group Type: ACTIVE_COMPARATOR

Surgery alone

Intervention Type: PROCEDURE

Evacuation of cSDH

Interventions

Surgery plus endovascular MMA embolization

A micro catheter is inserted transfemorally into the branches of the middle meningeal artery (MMA) in a minimally invasive manner and the periphery is occluded using polyvinyl alcohol (PVA) particles to prevent future bleeding. If the desired catheter position cannot be achieved due to the anatomical conditions, a more proximal closure of the MMA using Onyx® or micro-electric coils is performed. Embolization of the MMA by PVA particles with sizes between 40-300 µm is preferred over embolization by coils and Onyx®, since the capillary network of the dura is entirely blocked when using particles. In order to identify the vessels to be closed, a digital subtraction angiography (DSA) is performed.

Intervention Type: PROCEDURE

Surgery alone

Evacuation of cSDH

Intervention Type: PROCEDURE

Eligibility Criteria

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%

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unfallkrankenhaus Berlin

OTHER

Sponsor Role: lead

Responsible Party

Johannes Lemcke

Deputy Head Department of Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Unfallkrankenhaus Berlin

Berlin, State of Berlin, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Johannes Lemcke, PD Dr. med.

Role: CONTACT

johannes.lemcke@ukb.de

00493056813701

Leonie Goelz, Dr. med.

Role: CONTACT

leonie.goelz@ukb.de

Facility Contacts

Johannes Lemcke, Dr

Role: primary

johannes.lemcke@ukb.de

References

Hoenning A, Lemcke J, Rot S, Stengel D, Hoppe B, Zappel K, Schuss P, Mutze S, Goelz L. Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE): study protocol for a randomized controlled trial. Trials. 2022 Aug 22;23(1):703. doi: 10.1186/s13063-022-06506-3.

Reference Type: DERIVED

PMID: 35996195 (View on PubMed)

Other Identifiers

DRKS00020465

Identifier Type: OTHER

Identifier Source: secondary_id

MMA_SP

Identifier Type: -

Identifier Source: org_study_id