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

Not Applicable

Recruiting

• Conditions: Hematoma, Subdural, Chronic
• Interventions: Procedure: Surgery plus endovascular MMA embolization; Procedure: Surgery alone

• Registration Number: NCT05327933
• Lead Sponsor: Unfallkrankenhaus Berlin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-14
• Study Start: 2022-05-26
• Status Verified: 2024-12
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery plus endovascular MMA embolization	Surgery plus endovascular MMA embolization	-
Surgery alone	Surgery alone	-

Primary Outcome Measures

Name	Time	Method
cSDH recurrence rates after surgery	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 Outcome Measures

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

Trial Locations

Locations (1)

Unfallkrankenhaus Berlin; 🇩🇪 Berlin, Germany