---
title: Cerebrospinal Fluid Hemoglobin to Monitor for Aneurysmal Subarachnoid Hemorrhage Related Secondary Brain Injury
nct_id: NCT04998370
overall_status: COMPLETED
sponsor: University of Zurich
study_type: OBSERVATIONAL
primary_condition: Subarachnoid Hemorrhage, Aneurysmal
countries: Austria, Germany, Switzerland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04998370.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04998370"
ct_last_update_post_date: 2025-12-12
last_seen_at: "2026-05-12T07:04:50.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Cerebrospinal Fluid Hemoglobin to Monitor for Aneurysmal Subarachnoid Hemorrhage Related Secondary Brain Injury

**Official Title:** Hemoglobin in the Cerebrospinal Fluid to Monitor for Secondary Brain Injury After Aneurysmal Subarachnoid Hemorrhage - a Prospective Multinational Validation Study

**NCT ID:** [NCT04998370](https://clinicaltrials.gov/study/NCT04998370)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 366
- **Lead Sponsor:** University of Zurich
- **Conditions:** Subarachnoid Hemorrhage, Aneurysmal, Vasospasm, Delayed Cerebral Ischemia, Delayed Ischemic Neurological Deficit
- **Start Date:** 2021-08-18
- **Completion Date:** 2024-10-01
- **CT.gov Last Update:** 2025-12-12

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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.

## Primary Outcomes

- **Aneurysmal subarachnoid hemorrhage related secondary brain injury (SAH-SBI)** _(time frame: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)_ — Composite outcome consisting of angiographic vasospasms (aVSP), delayed cerebral ischemia (DCI), or delayed ischemic neurological deficits (DIND).

## Secondary Outcomes

- **Angiographic vasospasms (aVSP)** _(time frame: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)_
- **Delayed cerebral ischemia (DCI)** _(time frame: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)_
- **Delayed ischemic neurologic deficits (DIND)** _(time frame: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)_
- **Co-intervention 1: Nimodipine treatment** _(time frame: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)_
- **Co-intervention 2: Spasmolysis** _(time frame: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)_
- **Co-intervention 3: Intraventricular administration of rtPA (ICV-rtPA)** _(time frame: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)_
- **Co-intervention 4: Triple-H-therapy** _(time frame: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)_
- **Co-intervention 5: Decompression** _(time frame: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)_
- **Complication 1: CSF infection** _(time frame: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)_
- **Complication 2: Surgical site infection** _(time frame: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage)_
- **Chronic hydrocephalus** _(time frame: 12 weeks follow-up visit)_
- **Functional status 1: Glasgow Outcome Scale Extended [1-8]** _(time frame: 12 weeks follow-up visit)_
- **Functional status 2: modified Rankin Scale [0-6]** _(time frame: 12 weeks follow-up visit)_

## Locations (8)

- 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

## Recent Field Changes (last 30 days)

- `results.hasResults` — added _(2026-05-12)_
- `locations.johannes kepler universität linz, universitätsklinik für neurochirurgie|linz||austria` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `locations.medizinische universität wien, klinik für neurochirurgie|vienna||austria` — added _(2026-05-12)_
- `locations.universitätsklinikum mannheim|mannheim|baden-wurttemberg|germany` — added _(2026-05-12)_
- `locations.klinikum rechts der isar tum|münchen|bavaria|germany` — added _(2026-05-12)_
- `locations.universitätsklinikum tübingen|tübingen|tübingen|germany` — added _(2026-05-12)_
- `locations.kantonsspital aarau|aarau|canton of aargau|switzerland` — added _(2026-05-12)_
- `locations.kantonsspital st. gallen|sankt gallen|canton of st. gallen|switzerland` — added _(2026-05-12)_
- `locations.university hospital zurich|zurich|canton of zurich|switzerland` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04998370.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04998370*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*