Cerebrospinal Fluid Hemoglobin to Monitor for Aneurysmal Subarachnoid Hemorrhage Related Secondary Brain Injury

  • STATUS
    Recruiting
  • End date
    Nov 5, 2023
  • participants needed
    500
  • sponsor
    University of Zurich
Updated on 5 October 2021

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.

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.

Details
Condition Vasoconstriction, Subarachnoid Hemorrhage, Delayed Cerebral Ischemia, vasospasm, delayed cerebral ischaemia, Delayed Ischemic Neurological Deficit, Delayed Ischemic Neurological Deficit
Clinical Study IdentifierNCT04998370
SponsorUniversity of Zurich
Last Modified on5 October 2021

Eligibility

Yes No Not Sure

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
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