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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematoma, Subdural, Chronic
• Intervention / Treatment: Procedure: Surgery plus endovascular MMA embolization; Procedure: Surgery alone

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johannes Lemcke, PD Dr. med.; Phone Number: 00493056813701; Email: johannes.lemcke@ukb.de
• Study Contact Backup: Name: Leonie Goelz, Dr. med.; Email: leonie.goelz@ukb.de

Study Locations

• Germany
  • Berlin, Germany, 12683
    • Recruiting
    • Unfallkrankenhaus Berlin
    • Contact: Johannes Lemcke, Dr; Email: johannes.lemcke@ukb.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgery plus endovascular MMA embolization	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 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.
Active Comparator: Surgery alone	Procedure: Surgery alone; Evacuation of cSDH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within three months of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impairment due to neurological deficits assessed by the modified Rankin Scale	Modified Rankin scale ranges from 0 (no symptoms) to 5 (severe disability)	Evaluated at three months after baseline
Number of recurrence-associated complications	Examined on a binary scale	Within three months of follow-up
Number of complications associated with interventional therapy	Examined on a binary scale	Within three months of follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between factor XIII deficiency and risk of recurrence	Factor XIII deficiency is defined if the factor XIII concentration at baseline and/or the factor XIII activity after cryopreservation is <70%.	Within three months of follow-up
Predisposition of the genetic variants F13A1 rs2815822 and F13B rs12134960 for factor XIII deficiency	The existence of genetic variants F13A1 rs2815822 or F13B rs12134960 in the blood of the subjects is determined on a binary scale.	Within three months of follow-up

Collaborators and Investigators

• Sponsor: Unfallkrankenhaus Berlin

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Chronic Disease; Recurrence; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic
• Other Study ID Numbers: MMA_SP; DRKS00020465 (Other Identifier: German Clinical Trials Register)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No