Enhanced recovery pathway for burr-hole drainage in chronic subdural hematoma patients
Enhanced Recovery Pathway for Chronic Subdural Hematoma
This project tests whether an enhanced recovery protocol for adults having burr-hole drainage for chronic subdural hematoma can reduce recurrence and complications compared with past patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT07421453 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18+) with a chronic subdural hematoma requiring burr-hole drainage who can provide informed consent (or have a legally acceptable representative) are the intended participants.
Not a fit: Patients with significant underlying cerebral lesions (for example tumors or vascular lesions) or with prior treatment of the same-sided chronic subdural hematoma are excluded and thus unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the protocol could lower recurrence and complication rates and streamline recovery after burr-hole drainage for chronic subdural hematoma.
How similar studies have performed: Enhanced recovery protocols have improved outcomes in other surgical fields and smaller series suggest benefits for cSDH, but combining decision algorithms, surgical modifications, and embolization pathways in a single ERP is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Leuven
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.