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NCT Number: NCT05327933

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

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.

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Key information

Conditions

Hematoma, Subdural, Chronic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Craniocerebral Trauma Disease Attributes Hematoma Hematoma, Subdural Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unfallkrankenhaus Berlin

Berlin, State of Berlin, 12683, Germany

Location status: Recruiting

Location contact

Johannes Lemcke, Dr

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Surgery plus endovascular MMA embolization

Procedure

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

Procedure

Evacuation of cSDH

Primary outcomes

  1. 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

Secondary outcomes

  1. Impairment due to neurological deficits assessed by the modified Rankin Scale

    Time frame: Evaluated at three months after baseline

    Modified Rankin scale ranges from 0 (no symptoms) to 5 (severe disability)

  2. Number of recurrence-associated complications

    Time frame: Within three months of follow-up

    Examined on a binary scale

  3. Number of complications associated with interventional therapy

    Time frame: Within three months of follow-up

    Examined on a binary scale

Other outcomes

  1. Relationship between factor XIII deficiency and risk of recurrence

    Time frame: Within three months of follow-up

    Factor XIII deficiency is defined if the factor XIII concentration at baseline and/or the factor XIII activity after cryopreservation is <70%.

  2. Predisposition of the genetic variants F13A1 rs2815822 and F13B rs12134960 for factor XIII deficiency

    Time frame: Within three months of follow-up

    The existence of genetic variants F13A1 rs2815822 or F13B rs12134960 in the blood of the subjects is determined on a binary scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Johannes Lemcke, PD Dr. med.

CONTACT

[email protected]

00493056813701

Leonie Goelz, Dr. med.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Unfallkrankenhaus Berlin

Other

Registry information

Official study title

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

Acronym: MEMBRANE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2022
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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