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

NCT04998370 | Completed DMC

• 1 other identifier: 2021-01023
• Study Type: observational
• Target: 366
• Locations: 3 countries
• Sites: 8

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.

Conditions

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

Keywords

Cerebrospinal Fluid; Hemoglobins

Outcome Measures

Primary Outcomes (1)

• Aneurysmal subarachnoid hemorrhage related secondary brain injury (SAH-SBI)

  Composite outcome consisting of angiographic vasospasms (aVSP), delayed cerebral ischemia (DCI), or delayed ischemic neurological deficits (DIND).

  Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage

Secondary Outcomes (13)

• Angiographic vasospasms (aVSP)

  Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage

• Delayed cerebral ischemia (DCI)

  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 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

Other Outcomes (1)

• Cerebrospinal fluid hemoglobin

  Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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 EVD, while secondary objectives consider patients with both, EVD and LD as well as patients without any drainage system.

You may qualify if:

• age ≥ 18 years
• hospital admission due to an aneurysmal subarachnoid hemorrhage (diagnosis radiologically confirmed)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (8)

Johannes Kepler Universität Linz, Universitätsklinik für Neurochirurgie

Linz, 4040, Austria

Location

Medizinische Universität Wien, Klinik für Neurochirurgie

Vienna, 1090, Austria

Location

Universitätsklinikum Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Klinikum rechts der Isar TUM

München, Bavaria, 81675, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Tübingen, 72076, Germany

Location

Kantonsspital Aarau

Aarau, Canton of Aargau, CH-5001, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, CH-9007, Switzerland

Location

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35850705 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cerebrospinal fluid supernatant (after centrifugation)

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Hugelshofer, MD MSc

  University Hospital and University of Zurich, Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

• Kevin Akeret, MD/PhD

  University Hospital and University of Zurich, Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

• Dominik J Schaer, MD

  University Hospital and University of Zurich, Department of Internal Medicine

  STUDY CHAIR

• Raphael M Buzzi, MD/PhD

  University Hospital and University of Zurich, Department of Internal Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 10, 2021
• Study Start: August 18, 2021
• Primary Completion: September 30, 2024
• Study Completion: October 1, 2024
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

CH (3); DE (3); AU (2)