Hemoglobin in the Cerebrospinal Fluid to Monitor for Secondary Brain Injury After Aneurysmal Subarachnoid Hemorrhage - a Prospective Multinational Validation Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Sponsor
- University of Zurich
- Enrollment
- 366
- Locations
- 8
- Primary Endpoint
- Aneurysmal subarachnoid hemorrhage related secondary brain injury (SAH-SBI)
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
The primary objective of this study is to evaluate the association between hemoglobin levels in the cerebrospinal fluid (CSF-Hb) and the occurrence of secondary brain injury in patients after aneurysmal subarachnoid hemorrhage (SAH-SBI) during the first 14 days after bleeding.
Detailed Description
This is an international multicentre observational study to validate cerebrospinal fluid hemoglobin (CSF-Hb) as a monitoring biomarker for aneurysmal subarachnoid hemorrhage related secondary brain injury (SAH-SBI). It is hypothesized that there is an association between the concentration of CSF-Hb and the occurrence of SAH-SBI during the first 14 days after the bleeding (post-SAH). The primary objective of this study is to evaluate the association between ventricular CSF-Hb and SAH-SBI during the first 14 days post-SAH. The secondary objectives are to investigate: * the association between ventricular CSF-Hb and angiographic vasospasms (aVSP), delayed cerebral ischemia (DCI) and delayed ischemic neurological deficits (DIND) during the first 14 days post-SAH, * the accuracy of ventricular CSF-Hb to monitor for aVSP, DCI and DIND during the first 14 days post-SAH, * the association between lumbar CSF-Hb and SAH-SBI, aVSP, DCI and DIND during the first 14 days post-SAH, * the accuracy of lumbar CSF-Hb to monitor for aVSP, DCI and DIND during the first 14 days post-SAH, * the association between baseline measures and CSF-Hb (ventricular and lumbar during the first 14 days post-SAH), * the association between CSF-Hb (ventricular and lumbar during the first 14 days post-SAH) and co-interventions/complications, * the association between CSF-Hb (ventricular and lumbar during the first 14 days post-SAH) and chronic hydrocephalus at 12 weeks follow-up, * the association between CSF-Hb (ventricular and lumbar during the first 14 days post-SAH) and functional outcome at 12 weeks follow-up, * exploratory CSF proteome/metabolome analyses to assess Hb toxicity, inflammation, neuronal, or vascular damage.
Investigators
Michael Hugelshofer
Principal Investigator
University of Zurich
Eligibility Criteria
Inclusion Criteria
- •age ≥ 18 years
- •hospital admission due to an aneurysmal subarachnoid hemorrhage (diagnosis radiologically confirmed)
Exclusion Criteria
- •non-aneurysmal subarachnoid hemorrhage (eg. trauma, perimesencephalic subarachnoid hemorrhage).
- •participation in another study with CSF sampling or an interventional medical product within the 30 days preceding and during the present study.
- •previous enrolment into the current study
Outcomes
Primary Outcomes
Aneurysmal subarachnoid hemorrhage related secondary brain injury (SAH-SBI)
Time Frame: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage
Composite outcome consisting of angiographic vasospasms (aVSP), delayed cerebral ischemia (DCI), or delayed ischemic neurological deficits (DIND).
Secondary Outcomes
- Co-intervention 5: Decompression(Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)
- Chronic hydrocephalus(12 weeks follow-up visit)
- Angiographic vasospasms (aVSP)(Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)
- Delayed ischemic neurologic deficits (DIND)(Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)
- Co-intervention 4: Triple-H-therapy(Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)
- Complication 2: Surgical site infection(Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)
- Delayed cerebral ischemia (DCI)(Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)
- Co-intervention 3: Intraventricular administration of rtPA (ICV-rtPA)(Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)
- Co-intervention 1: Nimodipine treatment(Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)
- Co-intervention 2: Spasmolysis(Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)
- Complication 1: CSF infection(Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)
- Functional status 1: Glasgow Outcome Scale Extended [1-8](12 weeks follow-up visit)
- Functional status 2: modified Rankin Scale [0-6](12 weeks follow-up visit)