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

University of Zurich (UZH)

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT04998370

2021-01023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 366 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

366 participants in 1 patient group

Study cohort

Description:

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.