Preventing Recurrences of Chronic Subdural Hematoma in Adult Patients by Middle Meningeal Artery Embolization (MEMBRANE)
Primary Purpose
Hematoma, Subdural, Chronic
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Surgery plus endovascular MMA embolization
Surgery alone
Sponsored by
About this trial
This is an interventional prevention trial for Hematoma, Subdural, Chronic
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%
Sites / Locations
- Unfallkrankenhaus BerlinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Surgery plus endovascular MMA embolization
Surgery alone
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Impairment due to neurological deficits assessed by the modified Rankin Scale
Modified Rankin scale ranges from 0 (no symptoms) to 5 (severe disability)
Number of recurrence-associated complications
Examined on a binary scale
Number of complications associated with interventional therapy
Examined on a binary scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05327933
Brief Title
Preventing Recurrences of Chronic Subdural Hematoma in Adult Patients by Middle Meningeal Artery Embolization
Acronym
MEMBRANE
Official Title
Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Unfallkrankenhaus Berlin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematoma, Subdural, Chronic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgery plus endovascular MMA embolization
Arm Type
Experimental
Arm Title
Surgery alone
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Surgery plus endovascular MMA embolization
Intervention Description
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
Intervention Name(s)
Surgery alone
Intervention Description
Evacuation of cSDH
Primary Outcome Measure Information:
Title
cSDH recurrence rates after surgery
Description
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
Time Frame
Within three months of follow-up
Secondary Outcome Measure Information:
Title
Impairment due to neurological deficits assessed by the modified Rankin Scale
Description
Modified Rankin scale ranges from 0 (no symptoms) to 5 (severe disability)
Time Frame
Evaluated at three months after baseline
Title
Number of recurrence-associated complications
Description
Examined on a binary scale
Time Frame
Within three months of follow-up
Title
Number of complications associated with interventional therapy
Description
Examined on a binary scale
Time Frame
Within three months of follow-up
Other Pre-specified Outcome Measures:
Title
Relationship between factor XIII deficiency and risk of recurrence
Description
Factor XIII deficiency is defined if the factor XIII concentration at baseline and/or the factor XIII activity after cryopreservation is <70%.
Time Frame
Within three months of follow-up
Title
Predisposition of the genetic variants F13A1 rs2815822 and F13B rs12134960 for factor XIII deficiency
Description
The existence of genetic variants F13A1 rs2815822 or F13B rs12134960 in the blood of the subjects is determined on a binary scale.
Time Frame
Within three months of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johannes Lemcke, PD Dr. med.
Phone
00493056813701
Email
johannes.lemcke@ukb.de
First Name & Middle Initial & Last Name or Official Title & Degree
Leonie Goelz, Dr. med.
Email
leonie.goelz@ukb.de
Facility Information:
Facility Name
Unfallkrankenhaus Berlin
City
Berlin
ZIP/Postal Code
12683
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johannes Lemcke, Dr
Email
johannes.lemcke@ukb.de
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35996195
Citation
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.
Results Reference
derived
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Preventing Recurrences of Chronic Subdural Hematoma in Adult Patients by Middle Meningeal Artery Embolization
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