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Subarachnoid Hemorrhage, AneurysmalHeMoValNCT04998370

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

An observational study of Subarachnoid Hemorrhage, Aneurysmal and Vasospasm, run by University of Zurich at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
366 participants
Where
8 sitesin 3 countries
Study dates
18 Aug 2021to 1 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

Germany3 sites

  • Universitätsklinikum Mannheim

    Mannheim, Baden-Wurttemberg, 68167

  • Klinikum rechts der Isar TUM

    München, Bavaria, 81675

  • Universitätsklinikum Tübingen

    Tübingen, Tübingen, 72076

Other trials in Germany

Switzerland3 sites

  • Kantonsspital Aarau

    Aarau, Canton of Aargau, CH-5001

  • Kantonsspital St. Gallen

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

  • University Hospital Zurich

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Austria2 sites

  • Johannes Kepler Universität Linz, Universitätsklinik für Neurochirurgie

    Linz, 4040

  • Medizinische Universität Wien, Klinik für Neurochirurgie

    Vienna, 1090

Other trials in Austria

About this study

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

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.

Read the 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.
Keywords
Cerebrospinal Fluid, Hemoglobins
Medical subject headings
Subarachnoid Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04998370
Study groupRoleWhat they receive
Study cohortThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage

Secondary outcomes (13)

  1. Angiographic vasospasms (aVSP)

    The definition of aVSP comprises a narrowing of cerebral arteries based on a digital subtraction angiography (DSA), CT angiography (CTA) or magnetic resonance angiography (MRA). In the absence of an appropriate imaging procedure on the respective day, this will be noted as no imaging performed.

    Measured: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage

  2. Delayed cerebral ischemia (DCI)

    DCI is defined as new ischemia or new infarction on CT/perfusion CT or MRI. In the absence of an appropriate imaging procedure on the respective day, this will be noted as no imaging performed.

    Measured: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage

  3. Delayed ischemic neurologic deficits (DIND)

    DIND is defined as a new focal neurological deficit or a decrease in Glasgow Coma Scale (GCS) of at least 2 points for at least 2 hours. In case the patient cannot be clinically assessed (e.g., sedation), this will be noted as non-assessable).

    Measured: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage

  4. Co-intervention 1: Nimodipine treatment

    Whether the patient received preventive nimodipine treatment within the past 24 hours.

    Measured: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage

  5. Co-intervention 2: Spasmolysis

    Whether a rescue therapy with pharmacological spasmolysis or balloon angioplasty was performed within the past 24 hours.

    Measured: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage

  6. Co-intervention 3: Intraventricular administration of rtPA (ICV-rtPA)

    Whether rtPA was administered via the EVD to induce blood clot lysis within the past 24 hours.

    Measured: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage

  7. Co-intervention 4: Triple-H-therapy

    A triple-H-therapy or elements of it (hypertension, hypervolemia or hemodilution) was induced within the past 24 hours.

    Measured: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage

  8. Co-intervention 5: Decompression

    A surgical decompression (e.g. decompressive hemicraniectomy) was performed within the past 24 hours.

    Measured: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage

  9. Complication 1: CSF infection

    Differentiated between infection (Clinical symptoms and signs of CSF infection and positive CSF culture), colonization (2 positive CSF cultures without clinical symptoms and signs) and contamination (1 positive CSF culture with consecutive culture being negative).

    Measured: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage

  10. Complication 2: Surgical site infection

    Evidence for a surgical site infection at the EVD/LD skin entrance site.

    Measured: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage

  11. Chronic hydrocephalus

    Measured: 12 weeks follow-up visit

  12. Functional status 1: Glasgow Outcome Scale Extended [1-8]

    1. Death
    2. Vegetative state (unresponsive and speechless)
    3. Lower severe disability (requires frequent help of someone to be around at home most of the time every day)
    4. Upper severe diasbility (can be left alone > 8h during the day, but unable to travel and/or go shopping without assistance)
    5. Lower moderate disability (unable to work or only in sheltered workshop)
    6. Upper moderate disability (reduced work capacity; resumes <50% of the pre-injury level of social and leisure activities)
    7. Lower good recovery (minor problems that affect daily life; resumes >50% of the pre-injury level of social and leisure activities)
    8. Upper good recovery (no current problems related to the brain injury that affect daily life)

    Measured: 12 weeks follow-up visit

  13. Functional status 2: modified Rankin Scale [0-6]

    0 No symptoms

    1. No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. Moderate disability. Requires some helpt, but able to walk unassisted.
    4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. Dead

    Measured: 12 weeks follow-up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2021
  2. Study start18 Aug 2021
  3. Primary completion30 Sep 2024
  4. Study completion1 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04998370
Sponsor's protocol ID
2021-01023
Acronym
HeMoVal
Status last verified
Dec 2025
First submitted
19 Jul 2021
Last updated
12 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35850705

Questions about this trial

What is this clinical trial studying?

An observational study of Subarachnoid Hemorrhage, Aneurysmal and Vasospasm, run by University of Zurich at 8 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany, Switzerland, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aneurysmal subarachnoid hemorrhage related secondary brain injury (SAH-SBI) (time frame: Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04998370, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.

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