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Implementation of an Enhanced Recovery Pathway for Burr-hole Drainage in Patients With a Chronic Subdural Hematoma

Recruitingn/aAges 18 Years - anyAllUniversitaire Ziekenhuizen KU Leuven
NCT07421453 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

A chronic subdural hematoma (cSDH) is a type of intracranial hematoma that primarily affects older adults. The rising incidence of this condition, coupled with the high healthcare burden of this disease, calls for an update of the medical care program. We introduced an enhanced recovery protocol (ERP) at our center for patients undergoing surgical treatment (by means of burr-hole drainage) for a cSDH. Our ERP includes guidelines for treatment decisions (surgery or middle meningeal artery embolization), modifications in surgical techniques, and standardized postoperative management strategies. This study prospectively analyses the safety and efficacy of this enhanced recovery protocol for patients undergoing burr hole drainage of a chronic subdural hematoma. Safety and efficacy outcomes will be compared with outcomes of a historical patient cohort. Safety of the protocol will be measured

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18 years or older * Existence of a chronic subdural hematoma requiring burr-hole drainage * Written informed consent to participate in the study must be obtained from the subject. If the subject is not capable of self-consent, all efforts will be made to locate a legally acceptable representative to act on behalf of the subject. When the patient is considered capable to consent but physically unable to sign an informed consent form and a representative is not available an impartial witness can attend the informed consent process. Exclusion Criteria: * Existence of an important underlying cerebral lesion (e.g. a vascular lesion, tumor) * History of treatment (surgical or by middle meningeal artery embolization) of a same sided cSDH
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What it tests

  • Not listed
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Where

1 site
University Hospitals Leuven
Leuven, Belgium
🤝 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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