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| Name | Class |
|---|---|
| Innogenetics N.V., Belgium | UNKNOWN |
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Prospective clinical study to investigate the pathogenesis of Terson syndrome and the prognostic value of the CSF-biomarkers tau-protein and amyloid-β 40 and 42 in patients with aneurysmatic subarachnoid hemorrhage. Our two hypotheses are as follows:
In this prospective clinical study the pathogenesis of Terson syndrome and the prognostic value of the CSF-biomarkers tau-proteine and amyloid-β 40 and 42 in patients with aneurysmatic subarachnoidal hemorrhage are investigated. Intracranial opening pressure will be measured in patients requiring CSF-diversion for acute hydrocephalus and correlated with the incidence of Terson syndrome tested by an opthalmologic exam (group A: Terson syndrome positive, group B: Terson syndrome negative). CSF samples from external ventricular drainages are obtained at day 0, 2 and 6 and concentration of tau-protein and amyloid-β 40 and 42 are determined and correlated to secondary outcome measures such as delayed cerebral ischemia, clinical vasospasm, re-bleed, necessity for surgical intervention secondary to raised intracranial pressure or CSF-diversion. Outcome in terms of Glasgow-Outcome-Scale-Extended and Euro-Qol-5 will be assessed at 3, 6 and 12 months.
CSF from patients undergoing diagnostic or therapeutic tapping of their internal ventricles for normal pressure hydrocephalus or shunt diagnostics serve as a reference for CSF-biomarkers concentration in healthy individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subarachnoid hemorrhage with and without Terson syndrome | Patients with aneurysmatic subarachnoid hemorrhage with and without Terson syndrome |
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| Measure | Description | Time Frame |
|---|---|---|
| Intracranial pressure (ICP) in mmH20 | Initial ICP is measured in mmH20 after insertion of EVD with a riser tube or after insertion of an ICP-probe. | after insertion of EVD or ICP-probe (between day 0 and 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of CSF-protein phospho-tau | Concentration of CSF-protein phospho-tau taken from EVD-CSF | Day 0, 2, 6 |
| Concentration of CSF-protein amyloid-ß 40/42 | Concentration of CSF-protein phospho-tau taken from EVD-CSF |
| Measure | Description | Time Frame |
|---|---|---|
| Glasgow-Outcome-Scale-Extended (GOSE) | Health outcome is assessed by the study physicians or a study nurse using the Glasgow-Outcome-Scale-Extended (GOSE) with the help of family members if necessary. | initial, 3, 6, 12 months after SAH |
| Life quality (Euro-Qol-5) |
Inclusion Criteria:
Exclusion Criteria:
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Patients with aneurysmatic subarachnoid hemorrhage requiring CSF-diversion and/or intracranial pressure monitoring
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| Name | Affiliation | Role |
|---|---|---|
| Holger Joswig, M.D. | Cantonal Hospital St. Gallen, Dept. of Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cantonal Hospital St. Gallen | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26185328 | Derived | Joswig H, Fournier JY, Hildebrandt G, Stienen MN. Sentinel Headache: A Warning Sign Preceding Every Fourth Aneurysmal Subarachnoid Hemorrhage. AJNR Am J Neuroradiol. 2015 Sep;36(9):E62-3. doi: 10.3174/ajnr.A4467. Epub 2015 Jul 16. No abstract available. |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Cerebrospinal fluid
| Day 0, 2, 6 |
| Delayed cerebral ischemia | For the duration of their hospital stay (which can be expected to be an average of 3 to 5 weeks for SAH patients), occurrence of delayed cerebral schema, diagnosed by CT or MRI, is noted (number of patients of cohort). | Daily for the duration of hospital stay, an expected average of 3 to 5 weeks |
| Clinically manifest vasospasm | For the duration of their hospital stay (which can be expected to be an average of 3 to 5 weeks for SAH patients), occurrence of clinically manifest vasospasm is noted (number of patients of cohort). Screening will be performed daily by transcranial doppler and confirmation of diagnosis done by CTA or angiography. | Daily for the duration of hospital stay, an expected average of 3 to 5 weeks |
| Re-bleed | For the duration of their hospital stay (which can be expected to be an average of 3 to 5 weeks for SAH patients), occurrence of an intracranial re-bleed, diagnosed by CT or MRI, is noted (number of patients of cohort). | Daily for the duration of hospital stay, an expected average of 3 to 5 weeks |
| Surgery for refractory ICP (decompressive hemicraniectomy) | For the duration of their hospital stay (which can be expected to be an average of 3 to 5 weeks for SAH patients), the need for surgery for refractory ICP (decompressive hemicraniectomy) is noted (number of patients of cohort). Indication for surgery is made by the treating staff consultant based on ICP, CPP and clinical status. | Daily for the duration of hospital stay, an expected average of 3 to 5 weeks |
| Necessity of CSF-shunt | For the duration of their hospital stay (which can be expected to be an average of 3 to 5 weeks for SAH patients), the need for permanent CSF-diversion is noted (number of patients of cohort). Indication for permanent CSF-diversion (usually a ventriculoperitoneal shunt) is made by the treating staff consultant based on radiographic and clinical signs of hydrocephalus secondary to SAH. | Daily for the duration of hospital stay, an expected average of 3 to 5 weeks |
| Opthalmologic exam | Occurrence of Terson syndrome is assessed by fundoscopy with chemically dilated pupils (number of patients of cohort). Intraocular pressure (mmHg) is measured. | Day 0 to 3; before discharge if initial exam negative |
Life quality is assessed by the study physicians or a study nurse using the Euro-Qol-5 questionnaire with the help of family members if necessary. |
| initial, 3, 6, 12 months after SAH |
| Neuropsychological deficits | The Montreal Cognitive Assessment (MoCA) is performed at day 14 days. A neuropsychological assessment by a neuropsychologist will then be performed at 3 and 12 months after SAH and includes a combination of the following tests: Alertness (Testbatterie zur Aufmerksamkeitsprüfung, TAP 2.2), Go/Nogo (TAP 2.2), Geteilte Aufmerksamkeit (TAP 2.2), Deux Barrage (2002), Farbe-Wort-Interferenztest (FWIT, after J.R. Stroop, 1985), Regensburger Wortflüssigkeitstest (RWT (2000)), 5-Punkte-Test (HAMASCH, H5PT-R), Frontal Assessment Battery Bedside (FAB), Verbaler Lern- und Merkfähigkeitstest (VLMT), Rey Complex Figure Test (RCFT (1995)), Tiere-Wörter-Test of the test battery Consortium to Establish A Registry for Alzheimer (CERAD), Boston Naming Test (CERAD), Mini-Mental-Status-Examination (CERAD), Trail-Making-Test A (CERAD) and B (CERAD), S-Wörter-Test (CERAD), Apraxie-Prüfung (Goldenberg). Patients' cognitive status is graded as no (regular), or as minimal, moderate or severely disabled. | On day 14 and at 3 and 12 months |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |