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

Last updated: June 6, 2024
Sponsor: University of Zurich
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hemorrhage

Stroke

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT04998370
2021-01023
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age ≥ 18 years

  • hospital admission due to an aneurysmal subarachnoid hemorrhage (diagnosisradiologically confirmed)

Exclusion

Exclusion Criteria:

  • non-aneurysmal subarachnoid hemorrhage (eg. trauma, perimesencephalic subarachnoidhemorrhage).

  • participation in another study with CSF sampling or an interventional medicalproduct within the 30 days preceding and during the present study.

  • previous enrolment into the current study

Study Design

Total Participants: 409
Study Start date:
August 18, 2021
Estimated Completion Date:
October 31, 2024

Study 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.

Connect with a study center

  • Johannes Kepler Universität Linz, Universitätsklinik für Neurochirurgie

    Linz, 4040
    Austria

    Site Not Available

  • Medizinische Universität Wien, Klinik für Neurochirurgie

    Wien, 1090
    Austria

    Site Not Available

  • Universitätsklinikum Mannheim

    Mannheim, Baden-Württemberg 68167
    Germany

    Site Not Available

  • Klinikum rechts der Isar TUM

    München, Bayern 81675
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Kantonsspital Aarau

    Aarau, Aargau CH-5001
    Switzerland

    Site Not Available

  • Kantonsspital St. Gallen

    St. Gallen, Saint Gallen CH-9007
    Switzerland

    Site Not Available

  • University Hospital Zurich

    Zurich, 8091
    Switzerland

    Site Not Available

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