Implementation of an Enhanced Recovery Pathway for Burr-hole Drainage in Patients With a Chronic Subdural Hematoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Subdural Hematoma, Chronic Subdural Hematomas. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Enhanced Recovery Pathway for Chronic Subdural Hematoma
Overview
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.
Primary outcome measures
- Recurrence rate [Time frame: 6 months after surgery]
Secondary outcome measures (5)
- Length-of-stay [Time frame: Up to 6 months after surgery]
- Complication incidence [Time frame: 30 days after surgery]
- Mortality [Time frame: 30 days after surgery]
- 5-level EQ-5D (EQ-5D-5L) [Time frame: 6 months after surgery]
- modified Rankin Scale (mRS) [Time frame: 6 months after surgery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- University Hospitals Leuven — Leuven
Publications
- Link TW, Rapoport BI, Paine SM, Kamel H, Knopman J. Middle meningeal artery embolization for chronic subdural hematoma: Endovascular technique and radiographic findings. Interv Neuroradiol. 2018 Aug;24(4):455-462. doi: 10.1177/1591019918769336. Epub 2018 May 2. PMID 29720020
- Feghali J, Yang W, Huang J. Updates in Chronic Subdural Hematoma: Epidemiology, Etiology, Pathogenesis, Treatment, and Outcome. World Neurosurg. 2020 Sep;141:339-345. doi: 10.1016/j.wneu.2020.06.140. Epub 2020 Jun 25. PMID 32593768
Identifiers
NCT: NCT07421453 · S68819