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

RecruitingNAAges 18 Years - anyAllUnfallkrankenhaus Berlin
NCT05327933 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 i

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📋 Eligibility rules (as published)
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%
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What it tests

  • Surgery plus endovascular MMA embolization
  • Surgery alone
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Where

1 site
Unfallkrankenhaus Berlin
Berlin, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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