An observational study in Subarachnoid Hemorrhage, Terson Syndrome and CSF-proteines, sponsored by Holger Joswig. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-08.
Sponsored by Holger Joswig · Observational
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.
509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.
This study's planned enrollment of 120 is close to the median of 117 across 226 observational studies indexed under Subarachnoid Hemorrhage.
Browse Subarachnoid Hemorrhage studies →Holger Joswig is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with aneurysmatic subarachnoid hemorrhage requiring CSF-diversion and/or intracranial pressure monitoring
Exclusion Criteria:
Patients with aneurysmatic subarachnoid hemorrhage with and without Terson syndrome
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.
Time frame: after insertion of EVD or ICP-probe (between day 0 and 3)
Concentration of CSF-protein phospho-tau
Concentration of CSF-protein phospho-tau taken from EVD-CSF
Time frame: Day 0, 2, 6
Concentration of CSF-protein amyloid-ß 40/42
Concentration of CSF-protein phospho-tau taken from EVD-CSF
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0 to 3; before discharge if initial exam negative
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.
Time frame: initial, 3, 6, 12 months after SAH
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.
Time frame: 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.
Time frame: On day 14 and at 3 and 12 months
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Holger Joswig