Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05327933

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

Led by Unfallkrankenhaus Berlin · Updated on 2025-03-30

154

Participants Needed

1

Research Sites

174 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who have undergone surgery by means of one or more burr hole trepanations during the first manifestation of a chronic subdural hematoma detected by CT or MRI
  • Age 18 years or older
  • Sufficient compliance and ability to consent
  • Patient's informed consent for surgical and endovascular procedures and participation in the study
Not Eligible

You will not qualify if you...

  • Conservatively treated chronic subdural hematoma
  • Radiological evidence of acute or subacute subdural hematoma, subarachnoid hemorrhage, intracerebral hematoma, or epidural hematoma
  • Surgical techniques such as craniotomy, craniectomy, or bilateral burr hole trepanation
  • Angiography cannot be performed within 72 hours after surgery
  • Age under 18 years
  • Supervisory relationship
  • Pregnancy
  • Lack of informed consent
  • Lack of compliance
  • Homozygous factor XIII deficiency with residual activity less than 10%

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Unfallkrankenhaus Berlin

Berlin, State of Berlin, Germany, 12683

Actively Recruiting

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Research Team

J

Johannes Lemcke, PD Dr. med.

CONTACT

L

Leonie Goelz, Dr. med.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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