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

U

Unfallkrankenhaus Berlin

Status

Enrolling

Conditions

Hematoma, Subdural, Chronic

Treatments

Procedure: Surgery plus endovascular MMA embolization
Procedure: Surgery alone

Study type

Interventional

Funder types

Other

Identifiers

NCT05327933
DRKS00020465 (Other Identifier)
MMA_SP

Details and patient eligibility

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.

Enrollment

154 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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%

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

154 participants in 2 patient groups

Surgery plus endovascular MMA embolization
Experimental group
Treatment:
Procedure: Surgery plus endovascular MMA embolization
Surgery alone
Active Comparator group
Treatment:
Procedure: Surgery alone

Trial contacts and locations

1

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Central trial contact

Johannes Lemcke, PD Dr. med.; Leonie Goelz, Dr. med.

Data sourced from clinicaltrials.gov

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