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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27435

Enrollment

170

Registered

2020-10-02

Start date

2020-11-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic subdural hematoma

Interventions

Peri-operative embolization of the middle meningeal artery (until 72 hours after burr-hole evacuation).

Eligibility

Inclusion criteria

Inclusion criteria: - CT-confirmed diagnosis of cSDH - Primary surgical treatment based on clinical symptoms (progressive neurological deficits).

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
- The difference in reoperation rate between the control group and the intervention group	—

Secondary

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

Measure

Time frame

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

—

Contacts

Public ContactDagmar Verbaan

Amsterdam UMC

D.verbaan@amsterdamumc.nl020-5666564

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)