Chronic Subdural Hematoma Clinical Trials

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Enhanced Recovery Pathway for Chronic Subdural Hematoma

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
University Hospitals Leuven
RECRUITING
Leuven
Contact Information
Primary
Siebe Orolé, Medical degree
neurochirurgie@uzleuven.be
+32 16 34 42 90
Time Frame
Start Date: 2024-12-23
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 150
Treatments
ERP-cohort
Cohort of patients treated after ERP-implementation, prospective data collection
Pre-ERP-cohort
Patients treated before ERP-implementation, retrospective identified
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov