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

Organizational Data

DRKS-ID:
DRKS00020465
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2021-11-18
Last update in DRKS:
2023-12-07
Registration type:
Prospective

Acronym/abbreviation of the study

MEMBRANE

URL of the study

No Entry

Brief summary in lay language

Patients with a chronic subdural hematoma, 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.

Brief summary in scientific language

Data published retrospectively suggest that postoperative endovascular occlusion of the middle meningeal artery (MMA) branches reduces the risk of subsequent bleeding in chronic subdural hematoma (cSDH). The primary hypothesis of this prospective study is that the rate of recurrence of surgically treated cSDH can be reduced by an additional endovascular embolization of the MMA branches. In addition, it is to be investigated whether the impairment after neurological failures recorded by the modified Rankin scale (mRS) and the number of recurrence-associated complications can be reduced. Patients of full age can participate in the study after burr hole trepanation as a first operation. Participating patients are randomized into the control arm with treatment according to clinical routine or into the treatment arm with additional endovascular embolization of the MMA branches. In addition, patients can consent to a genetic examination in which the relationship between factor XIII deficiency and risk of recurrence and a predisposition of genetic variants for factor XIII deficiency are to be analyzed. To record the test results, follow-up examinations are carried out after one and three months.

Health condition or problem studied

ICD10:
I62.02
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Embolization of the branches of the MMA using digital subtraction angiography
Arm 2:
Treatment according to clinical routine

Endpoints

Primary outcome:
Recurrence of cSDH after operative therapy within 3 months after inclusion.
Secondary outcome:
1. Impairment through neurological deficits assessed by the modified Rankin scale (mRS) 3 months after inclusion 2. Number of recurrence-associated complications with within 3 months of inclusion 3. 2. Number of complications associated with interventional therapy within 3 months of inclusion

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Medical center BG Klinikum Unfallkrankenhaus Berlin gGmbH Berlin

Recruitment period and number of participants

Planned study start date:
2022-04-13
Actual study start date:
2022-05-26
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
154
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
1.Patients who were operated on by one or more burr hole trepanations for a first manifestation of a cSDH (unihemispheric or bihemispherical) proven in computer tomography or magnetic resonance tomography 2. Age ≥18 years 3. Adequate compliance and capacity to consent 4. Declaration of consent for the operation and study participation by the patient

Exclusion Criteria

1. Conservatively treated cSDH 2. Radiological detection of an acute or subacute subdural hematoma, subarachnoid hemorrhage, intracerebral hematoma, 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. No declaration of consent 9. Lack of compliance 10. Homozygous factor XIII deficiency with RA <10%

Addresses

Primary Sponsor

Klinik für Neurochirurgie BG Klinikum Unfallkrankenhaus Berlin gGmbH
PD Dr. med. Johannes Lemcke
Warener Straße 7
12683 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für Neurochirurgie BG Klinikum Unfallkrankenhaus Berlin gGmbH
PD Dr. med. Johannes Lemcke
Warener Straße 7
12683 Berlin
Germany
Telephone:
030-56813720
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Institut für Radiologie und Neuroradiologie BG Klinikum Unfallkrankenhaus Berlin gGmbH
Dr. med. Leonie Gölz
Warener Straße 7
12683 Berlin
Germany
Telephone:
030-56813829
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Klinik für Neurochirurgie BG Klinikum Unfallkrankenhaus Berlin gGmbH
PD Dr. med. Johannes Lemcke
Warener Straße 7
12683 Berlin
Germany
Telephone:
030-56813720
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)

Deutsche Gesetzliche Unfallversicherung e.V.
Alte Heerstr. 111
53757 Sankt Augustin
Germany
Telephone:
030 13001-2045
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Charité – Universitätsmedizin Berlin
Charitéplatz 1
10117 Berlin
Germany
Telephone:
(+49)30-450517222
Fax:
(+49)30-450517952
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2019-09-27
Ethics committee number:
EA1/119/19
Vote of the Ethics Committee:
Approved
Date of the vote:
2019-10-09

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
For reasons of data protection, no individual patient data is provided.

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry