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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebrospinal fluid hemoglobin | CSF sampling: CSF sampling will be performed via EVD or LD, depending on the patient's access to the CSF space. The decision regarding the insertion of an EVD or LD is made independently of this study and according to the clinical standard of care. 2ml of CSF will be sampled on a daily basis at approximately the same time in the morning. CSF centrifugation and storage: Immediately after sample collection, the CSF will be centrifuged at 1500 G for 15 minutes. The cell-free CSF supernatant will be stored at -80°C until analysis. Spectrophotometric cerebrospinal fluid hemoglobin (CSF-Hb) measurements: Absorption spectra in the visual range between 350 and 650 nm of all CSF samples will be measured. Quantification of oxyhemoglobin in CSF (CSF-Hb) will be performed using spectral deconvolution. |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johannes Kepler Universität Linz, Universitätsklinik für Neurochirurgie | Linz | 4040 | Austria | |||
| Medizinische Universität Wien, Klinik für Neurochirurgie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35850705 | Derived | 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. |
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Cerebrospinal fluid supernatant (after centrifugation)
| 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. | Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage |
| 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). | Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage |
| Co-intervention 1: Nimodipine treatment | Whether the patient received preventive nimodipine treatment within the past 24 hours. | Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage |
| Co-intervention 2: Spasmolysis | Whether a rescue therapy with pharmacological spasmolysis or balloon angioplasty was performed within the past 24 hours. | Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage |
| 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. | Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage |
| 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. | Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage |
| Co-intervention 5: Decompression | A surgical decompression (e.g. decompressive hemicraniectomy) was performed within the past 24 hours. | Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage |
| 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). | Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage |
| Complication 2: Surgical site infection | Evidence for a surgical site infection at the EVD/LD skin entrance site. | Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage |
| Chronic hydrocephalus | 12 weeks follow-up visit |
| Functional status 1: Glasgow Outcome Scale Extended [1-8] |
| 12 weeks follow-up visit |
| Functional status 2: modified Rankin Scale [0-6] | 0 No symptoms
| 12 weeks follow-up visit |
| Day 1 to day 14 after the aneurysmal subarachnoid hemorrhage |
| Vienna |
| 1090 |
| Austria |
| Universitätsklinikum Mannheim | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Klinikum rechts der Isar TUM | München | Bavaria | 81675 | Germany |
| Universitätsklinikum Tübingen | Tübingen | Tübingen | 72076 | Germany |
| Kantonsspital Aarau | Aarau | Canton of Aargau | CH-5001 | Switzerland |
| Kantonsspital St. Gallen | Sankt Gallen | Canton of St. Gallen | CH-9007 | Switzerland |
| University Hospital Zurich | Zurich | Canton of Zurich | 8091 | Switzerland |
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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