Preventing Recurrences of Chronic Subdural Hematoma in Adult Patients by Middle Meningeal Artery Embolization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgery plus endovascular MMA embolization, Surgery alone.
- Who it may be relevant to
- Registry conditions: Hematoma, Subdural, Chronic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE)
Overview
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.
Interventions
- Procedure 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 - Procedure Surgery alone
Evacuation of cSDH
Primary outcome measures
- cSDH recurrence rates after surgery [Time frame: Within three months of follow-up]
Secondary outcome measures (3)
- Impairment due to neurological deficits assessed by the modified Rankin Scale [Time frame: Evaluated at three months after baseline]
- Number of recurrence-associated complications [Time frame: Within three months of follow-up]
- Number of complications associated with interventional therapy [Time frame: Within three months of follow-up]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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%
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Germany · 1 center
- Unfallkrankenhaus Berlin — Berlin
Publications
- 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. PMID 35996195
Identifiers
NCT: NCT05327933 · MMA_SP · DRKS00020465