Implementation of an Enhanced Recovery Pathway for Burr-hole Drainage in Patients With a Chronic Subdural Hematoma
Recruiting now
Conditions studied: Chronic Subdural Hematoma, Chronic Subdural Hematomas
In brief
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.
Key facts
- Study ID
- NCT07421453
- Run by
- Universitaire Ziekenhuizen KU Leuven
- People needed
- 150
- Starts
- 2024-12-23
- Expected to finish
- 2028-07-31
- Last updated by the study team
- 2026-02-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- University Hospitals Leuven — Leuven, Belgium (enrolling)
Full record on ClinicalTrials.gov
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