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

NCT05327933 | Recruiting

• 2 other identifiers: MMA_SPDRKS00020465
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematoma, Subdural, Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Impairment due to neurological deficits assessed by the modified Rankin Scale

  Evaluated at three months after baseline

• Number of recurrence-associated complications

  Within three months of follow-up

• Number of complications associated with interventional therapy

  Within three months of follow-up

Other Outcomes (2)

• Relationship between factor XIII deficiency and risk of recurrence

  Within three months of follow-up

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

  Within three months of follow-up

Study Arms (2)

Surgery plus endovascular MMA embolization

EXPERIMENTAL

Procedure: Surgery plus endovascular MMA embolization

Surgery alone

ACTIVE COMPARATOR

Procedure: Surgery alone

Interventions

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 plus endovascular MMA embolization

Surgery alone PROCEDURE

Evacuation of cSDH

Surgery alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Unfallkrankenhaus Berlin: lead

Study Sites (1)

Unfallkrankenhaus Berlin

Berlin, State of Berlin, 12683, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 35996195 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Johannes Lemcke, PD Dr. med.

CONTACT

00493056813701; johannes.lemcke@ukb.de

Leonie Goelz, Dr. med.

CONTACT

leonie.goelz@ukb.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head Department of Neurosurgery

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 14, 2022
• Study Start: May 26, 2022
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 30, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)