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

NCT ID: NCT04998370

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 366 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-18
• Study Completion Date: 2024-10-01

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.

Conditions

Subarachnoid Hemorrhage, Aneurysmal; Vasospasm; Delayed Cerebral Ischemia; Delayed Ischemic Neurological Deficit

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study cohort

The study population consists of patients admitted to an academic tertiary care center due to an aneurysmal subarachnoid hemorrhage. The primary objective of the study focuses on patients included with external ventricular drain (EVD), while secondary objectives consider patients with both EVD and lumbar drain (LD) as well as patients without any drainage system.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Michael Hugelshofer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Hugelshofer, MD MSc

Role: PRINCIPAL_INVESTIGATOR

University Hospital and University of Zurich, Department of Neurosurgery

Kevin Akeret, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital and University of Zurich, Department of Neurosurgery

Dominik J Schaer, MD

Role: STUDY_CHAIR

University Hospital and University of Zurich, Department of Internal Medicine

Raphael M Buzzi, MD/PhD

Role: STUDY_CHAIR

University Hospital and University of Zurich, Department of Internal Medicine

Locations

Johannes Kepler Universität Linz, Universitätsklinik für Neurochirurgie

Linz, , Austria

Medizinische Universität Wien, Klinik für Neurochirurgie

Vienna, , Austria

Universitätsklinikum Mannheim

Mannheim, Baden-Wurttemberg, Germany

Klinikum rechts der Isar TUM

München, Bavaria, Germany

Universitätsklinikum Tübingen

Tübingen, Tübingen, Germany

Kantonsspital Aarau

Aarau, Canton of Aargau, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Countries

Austria; Germany; Switzerland

References

Akeret K, Buzzi RM, Saxenhofer M, Bieri K, Chiavi D, Thomson BR, Gruttner-Durmaz M, Schwendinger N, Humar R, Regli L, van Doormaal TPC, Held U, Keller E, Hugelshofer M, Schaer DJ; HeMoVal Research Group. The HeMoVal study protocol: a prospective international multicenter cohort study to validate cerebrospinal fluid hemoglobin as a monitoring biomarker for aneurysmal subarachnoid hemorrhage related secondary brain injury. BMC Neurol. 2022 Jul 18;22(1):267. doi: 10.1186/s12883-022-02789-w.

Reference Type: DERIVED

PMID: 35850705 (View on PubMed)

Other Identifiers

2021-01023

Identifier Type: -

Identifier Source: org_study_id