The usefulness of measuring oxygen and metabolites in the brain after aneurysm rupture in preventing secondary stroke
Phase 3
Completed
- Conditions
- Delayed cerebral ischemia occurring after subarachnoid hemorrhage.Circulatory SystemSequelae of subarachnoid haemorrhage
- Registration Number
- ISRCTN16523175
- Lead Sponsor
- niversity Hospital Aachen
- Brief Summary
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32413866/ (added 08/09/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 190
Inclusion Criteria
1. Suffered an aneurysmal subarachnoid hemorrhage.
2. Aged between 18 and 99 years old.
3. The hemorrhage has to present with a Hund & Hess grade of 3 or higher.
Exclusion Criteria
1. The occurrence of early angiographical vasospasms in the first diagnostic angiography.
2. Subarachnoid hemorrhage not cause by aneurysm rupture.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical outcomes as measured using the extended Glasgow outcome scale after 12 months. Data is collected prospectively during regular follow-ups and missing information is either appended by analysis of patients files or a structured telephone interview by a blinded assessor.
- Secondary Outcome Measures
Name Time Method <br> 1. GOS-E at discharge; GOS-E at 6 months measured and evaluated as mentioned above.<br> 2. Overall mortality.<br> 3. The lag between ictus and first treatment triggering DCI event (days), as is clear from patients files.<br> 4. The absolute number of CT investigations performed during the DCI time frame, in every patient. This as an indirect measurement of reliance in clinical decision making, on the measurements made by the invasive monitoring.<br> 5. The prevalence of silent infarctions (the occurrence of a demarcated infarction as the first sign of ongoing DCI). This is measured by investigation of patients CT and/or MRI images by a blinded observer.<br> 6. The prevalence of overall DCI related infarction as is apparent in clinical files and medical imaging.<br> 7. The prevalence of DCI related mortality, as is apparent in clinical files.<br>