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

Hematoma, Subdural, Chronic Clinical Trial

— MEMBRANE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05327933
• Other study ID #: MMA_SP
• Secondary ID: DRKS00020465
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2022
• Est. completion date: October 2025

Study information

• Verified date: November 2023
• Source: Unfallkrankenhaus Berlin
• Contact: Johannes Lemcke, PD Dr. med.
• Phone: 00493056813701
• Email: johannes.lemcke[@]ukb.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Hematoma
• Hematoma, Subdural, Chronic
• Recurrence

Intervention

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.
• Surgery alone
Evacuation of cSDH

Locations

Country	Name	City	State
Germany	Unfallkrankenhaus Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Unfallkrankenhaus Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	Number of recurrence-associated complications	Examined on a binary scale	Within three months of follow-up
Secondary	Number of complications associated with interventional therapy	Examined on a binary scale	Within three months of follow-up