Middle meningeal artery embolization for chronic subdural hematoma: Endovascular technique and radiographic findings.
Thomas W Link, Benjamin I Rapoport, Stephanie M Paine...
https://pubmed.ncbi.nlm.nih.gov/29720020Actively Recruiting
Age: 18Years +
All Genders
ID07421453
Enhanced Recovery Pathway for Chronic Subdural Hematoma
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-02-19
150
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic subdural hematoma (cSDH) is a type of brain bleed that mainly affects older adults and presents a growing healthcare challenge. Researchers are evaluating a new enhanced recovery protocol (ERP) designed to improve care for patients undergoing burr-hole drainage surgery for cSDH. This study compares the safety and effectiveness of the ERP with outcomes from previous patients treated before the protocol was introduced. The enhanced recovery protocol includes updated guidelines for choosing treatment options, such as surgery or middle meningeal artery embolization, improvements in surgical techniques, and standardized postoperative care. Patients treated after implementing the ERP are followed prospectively, while data from patients treated before the ERP are collected retrospectively for comparison. Participants will be monitored for safety by tracking recurrence of the hematoma over six months, incidence of complications, and mortality within 30 days after surgery. Effectiveness is assessed by measuring the length of hospital stay. Additional assessments include quality of life using the EQ-5D-5L and functional outcome with the modified Rankin Scale at six months. The total duration of follow-up is six months after surgery.
CONDITIONS
Brief Title
Implementation of an Enhanced Recovery Pathway for Burr-hole Drainage in Patients With a Chronic Subdural Hematoma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of chronic subdural hematoma requiring burr-hole drainage
- Provided written informed consent or consent by a legally acceptable representative if unable to self-consent
- If physically unable to sign and no representative available, consent process can involve an impartial witness
You will not qualify if you...
- Presence of significant underlying brain lesions, such as vascular lesions or tumors
- Previous treatment of the same sided chronic subdural hematoma by surgery or middle meningeal artery embolization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to several days
Participants undergo burr-hole drainage surgery for chronic subdural hematoma followed by immediate recovery care.
1 surgical visit and several immediate post-operative assessments
Post-operative Follow-up
Duration - Up to 6 months after surgery
Participants are monitored for complications, recovery progress, and outcomes after surgery.
Approximately 6 post-operative visits
Trial Site Locations
Total: 1 location
1
University Hospitals Leuven
Leuven, Belgium, 3000
Actively Recruiting
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Research Team
S
Siebe Orolé, Medical degree
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Updates in Chronic Subdural Hematoma: Epidemiology, Etiology, Pathogenesis, Treatment, and Outcome.
James Feghali, Wuyang Yang, Judy Huang
https://pubmed.ncbi.nlm.nih.gov/32593768