Hemoglobin in the Cerebrospinal Fluid to Monitor for Secondary Brain Injury After Aneurysmal Subarachnoid Hemorrhage - a Prospective Multinational Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 366
- 试验地点
- 8
- 主要终点
- Aneurysmal subarachnoid hemorrhage related secondary brain injury (SAH-SBI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •hospital admission due to an aneurysmal subarachnoid hemorrhage (diagnosis radiologically confirmed)
排除标准
- •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
结局指标
主要结局
Aneurysmal subarachnoid hemorrhage related secondary brain injury (SAH-SBI)
时间窗: 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).
次要结局
- 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)
研究者
Michael Hugelshofer
Principal Investigator
University of Zurich