Improving the outcome of chronic subdural hematoma by embolization of the middle meningeal artery

Recruiting

Conditions: Chronic subdural hematoma

Registration Number: NL-OMON27435

Lead Sponsor: Amsterdam University Medical Centers, AMC.

Brief Summary: .a.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 170

Inclusion Criteria

CT-confirmed diagnosis of cSDH

- Primary surgical treatment based on clinical symptoms (progressive neurological deficits).

Exclusion Criteria

- Significant contraindication to angiography (eg. allergy for contrast)

- Structural causes for subdural hemorrhage, e.g. arachnoid cysts, cortical vascular malformations and a history of cranial surgery in the previous 365 days

- Inability to obtain informed consent from the patient or legal representative (when the patient has a depressed level of consciousness), including language barrier.

- Monocular blindness on contralateral side of the hematoma

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- The difference in reoperation rate between the control group and the intervention group<br>

Secondary Outcome Measures

Name	Time	Method
<br>- Volume/size of cSDH at eight, 16 and 24 weeks on follow-up CT scan of the head<br>- Number of procedure related complications during hospital admission and 24 week follow-up.<br>- Neurological impairment at eight and 24 weeks, measured with the modified National Institutes of Health Stroke Scale (mNIHSS )<br>score.<br>- Functional outcome at 24 weeks, measured with the modified Rankin Scale (mRS) score.<br>- Cognitive functioning at eight, 16 weeks and 24 measured with the Montreal Cognitive Assessment (MOCA) test.<br>- Mortality at 24 weeks.<br>- Performance in activities of daily living at 24 weeks, measured with the AMC linear disability scale.<br>- Quality of life at 24 weeks, measured with the<br>a. Short Form Health Survey (SF-36) questionnaire;<br>b. five dimensional EuroQol (EQ-5D-3L) questionnaire.<br>- Care and health-related costs during the 24 week study period, measured with the<br>a. Medical Consumption Questionnaire (iMCQ);<br>b. Productivity Cost Questionnaire (iPCQ).<br>