Status:
UNKNOWN
Endovascular Embolization of Chronic Subdural Hematomas After Surgery
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Conditions:
Chronic Subdural Hematoma
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Chronic subdural hematomas (CSH) are one of the most frequent pathologies in emergency neurosurgical practice. Standard therapy for symptomatic CSH is surgical drainage. However, the recurrence rate a...
Detailed Description
The study was designed as an open-label, multicenter randomized trial involving patients with symptomatic CSH and surgical evacuation criteria. Patients will be randomized in a 1: 1 ratio to receive s...
Eligibility Criteria
Inclusion
- Chronic subdural hematoma equal or greater than 10 mm, midline shift equal or greater than 5 mm or neurological symptoms attributable to mass effect.
- Recent diagnosis or recurrence
- Surgical treatment performed \< 72 hours
- Informed consent signed by the patient or they responsible family member
Exclusion
- Advanced disease with life expectancy \< 6 months
- Condition that contraindicated endovascular procedure: Pregnancy, renal failure defined as creatinine clearence \< 30 ml/min, allergy to iodinated contrast.
- Unavailability for follow up st 6 months
- Patient expressly refuses treatment
Key Trial Info
Start Date :
February 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT05220826
Start Date
February 11 2022
End Date
December 1 2023
Last Update
March 21 2022
Active Locations (1)
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1
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035