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RECRUITINGOBSERVATIONAL

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

Enhanced Recovery Pathway for Chronic Subdural Hematoma

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 in terms of recurrence rate (6-month follow-up, primary outcome), complication incidence, and 30-day mortality. Efficacy of the enhanced recovery protocol will be represented by the length-of-stay.

Who May Be Eligible (Plain English)

Who May Qualify: - Age 18 years or older - Existence of a chronic subdural hematoma requiring burr-hole drainage - Written willing to sign a consent form 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 willing to sign a consent form form and a representative is not available an impartial witness can attend the willing to sign a consent form process. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Locations (1)

University Hospitals Leuven
Leuven, Belgium