bleeding in the subdural space stroke bleeding in the subdural space stroke
Conditions
Interventions
Peri-operative embolization until 72 hours after surgery.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Has a head-CT or MRI 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, inability to lay still); - Structural causes for subdural haemorrhage, e.g. arachnoid cysts, cortical vascular malformations and a history of cranial surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in reoperation rate between the control group and the intervention group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Volume/size of cSDH at 12 and 24 weeks on follow-up CT scan of the head. 2. Number of procedure related complications during hospital admission and 24 week follow-up. 3. Neurological impairment at 12and 24 weeks, measured with the modified National Institutes of Health Stroke Scale (mNIHSS ) score and Markwalder score. 4. Functional outcome at 24 weeks, measured with the modified Rankin Scale (mRS) score. 5. Cognitive functioning at 12 weeks and 24 measured with the Montreal Cognitive Assessment (MOCA) test and m-TICS. 6. Mortality at 24 weeks. 7. Performance in activities of daily living at 24 weeks, measured with the Barthel Index. 8. 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. 9 Care and health-related costs during the 24 week study period, measured with the a. Medical Consumption Questionnaire (iMCQ); b. Productivity Cost Questionnaire (iPCQ). | — |
Countries
Netherlands
Contacts
Public ContactMF Serlé
Amsterdam UMC
Outcome results
None listed