Hematoma, Subdural, ChronicMEMBRANENCT05327933
Preventing Recurrences of Chronic Subdural Hematoma in Adult Patients by Middle Meningeal Artery Embolization
A study testing Surgery plus endovascular MMA embolization and Surgery alone in people with Hematoma, Subdural, Chronic, run by Unfallkrankenhaus Berlin at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematoma, Subdural, Chronic
- What is being tested?
- Surgery plus endovascular MMA embolization and Surgery alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteGermany
- Study dates
- 26 May 2022to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Pregnancy
- Lack of informed consent
- Lack of compliance
- Homozygous factor XIII deficiency with residual activity <10%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Leonie Goelz, Dr. med. contact
Germany1 site, 1 recruiting
- Recruiting
Unfallkrankenhaus Berlin
Berlin, State of Berlin, 12683
Johannes Lemcke, Dr, johannes.lemcke@ukb.de
About this study
Official title: Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE)
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
- Being tested
- Surgery plus endovascular MMA embolization, Surgery alone
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery plus endovascular MMA embolizationProcedure or surgery
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 aloneProcedure or surgery
Evacuation of cSDH
| Study group | Role | What they receive |
|---|---|---|
| Surgery plus endovascular MMA embolization | Experimental | Not described Receives: Procedure: Surgery plus endovascular MMA embolization |
| Surgery alone | Active comparator | Not described Receives: Procedure: Surgery alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
cSDH recurrence rates after surgery
A recurrence occurs when at least one of the following criteria is met:
- recurrent cSDH with at least the same volume (>- 10%) compared to the findings at baseline and / or
- recurrent cSDH which requires surgery
Measured: Within three months of follow-up
Secondary outcomes (3)
Impairment due to neurological deficits assessed by the modified Rankin Scale
Modified Rankin scale ranges from 0 (no symptoms) to 5 (severe disability)
Measured: Evaluated at three months after baseline
Number of recurrence-associated complications
Examined on a binary scale
Measured: Within three months of follow-up
Number of complications associated with interventional therapy
Examined on a binary scale
Measured: Within three months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start26 May 2022
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematoma, Subdural, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unfallkrankenhaus Berlin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Lemcke, Unfallkrankenhaus Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327933
- Sponsor's protocol ID
- MMA_SP
- Other IDs
- DRKS00020465
- Acronym
- MEMBRANE
- Status last verified
- Dec 2024
- First submitted
- 6 Apr 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35996195
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE)
- ClinicalTrials.gov ID
- NCT05327933
- Acronym / sponsor ID
- MEMBRANE / MMA_SP
- Conditions
- Hematoma, Subdural, Chronic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Unfallkrankenhaus BerlinUniversity, hospital or other
- Study start
- 26 May 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery plus endovascular MMA embolization | Experimental | Procedure: Surgery plus endovascular MMA embolization |
| Surgery alone | Active comparator | Procedure: Surgery alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery plus endovascular MMA embolizationA 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. | Procedure or surgery | Surgery plus endovascular MMA embolization |
| Surgery aloneEvacuation of cSDH | Procedure or surgery | Surgery alone |
Primary outcome
cSDH recurrence rates after surgery
Time frame: Within three months of follow-up
A recurrence occurs when at least one of the following criteria is met: * recurrent cSDH with at least the same volume (>- 10%) compared to the findings at baseline and / or * recurrent cSDH which requires surgery
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 35996195Hoenning 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leonie Goelz, Dr. med. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery plus endovascular MMA embolization and Surgery alone in people with Hematoma, Subdural, Chronic, run by Unfallkrankenhaus Berlin at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johannes Lemcke, PD Dr. med. (00493056813701, johannes.lemcke@ukb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cSDH recurrence rates after surgery (time frame: Within three months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05327933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.