Subarachnoid Hemorrhage Clinical Trial
Official title:
The Pathogenesis of Terson Syndrome and the Role of CSF Tau / Amyloid-ß 40 and 42 in Patients With Aneurysmatic Subarachnoid Hemorrhage
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:
1. The incidence of Terson syndrome correlates with the initial intracranial opening
pressure (measured with extra ventricular drain)
2. The CSF-biomarkers correlate with the outcome assessed at discharge, 3-, 6- and
12-months postictally using Glasgow-Outcome-Scale-Extended (GOSE) and Euro-Qol-5 as
well as with complications related to aneurysmatic subarachnoid hemorrhage such as
cerebral vasospasm, delayed cerebral ischemia and re-bleed.
Status | Completed |
Enrollment | 120 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - older than 18 years - diagnosis of subarachnoid hemorrhage secondary to an intracranial aneurysm - aneurysmatic subarachnoid hemorrhage must be the principal diagnosis for hospitalization - an intracranial aneurysm must be confirmed by imaging (Computed tomography, magnet resonance tomography or angiography) - Patients requiring diagnostic/therapeutic tapping of their internal ventricles for CSF-diversion (shunt) for normal pressure hydrocephalus or shunt diagnostics serve as a control group - informed consent Exclusion Criteria: - younger than 18 years - other diagnosis such as traumatic or perimesencephalic subarachnoid hemorrhage without an intracranial aneurysm |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Switzerland | Cantonal Hospital St. Gallen | St. Gallen |
Lead Sponsor | Collaborator |
---|---|
Holger Joswig | Innogenetics N.V., Belgium |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | No |
Other | Life quality (Euro-Qol-5) | 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 | No |
Other | 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 | No |
Primary | 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) | No |
Secondary | Concentration of CSF-protein phospho-tau | Concentration of CSF-protein phospho-tau taken from EVD-CSF | Day 0, 2, 6 | No |
Secondary | Concentration of CSF-protein amyloid-ß 40/42 | Concentration of CSF-protein phospho-tau taken from EVD-CSF | Day 0, 2, 6 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
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