Enhanced recovery pathway for burr-hole drainage in chronic subdural hematoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational project implements a standardized enhanced recovery protocol (ERP) for patients undergoing burr-hole drainage of chronic subdural hematoma and compares outcomes to a historical cohort. The ERP includes decision guidelines (surgery versus middle meningeal artery embolization), specific surgical technique modifications, and uniform postoperative care pathways. Primary safety outcome is hematoma recurrence at six months, with additional measures of complication rates and 30-day outcomes. Eligible adults treated at the center without major underlying cerebral lesions are enrolled and outcomes are tracked prospectively.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospitals Leuven
  Leuven, Belgium Recruiting

Study contacts

• Principal investigator: Thomas Decramer, MD, PhD — Universitaire Ziekenhuizen KU Leuven
• Study coordinator: Siebe Orolé, Medical degree
• Email: neurochirurgie@uzleuven.be
• Phone: +32 16 34 42 90

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.