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The Pathogenesis of Terson Syndrome and the Role of CSF Tau / Amyloid-ß 40 and 42 in Patients With Aneurysmatic Subarachnoid Hemorrhage

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ClinicalTrials.gov Identifier: NCT02129010
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : March 8, 2016
Sponsor:
Collaborator:
Innogenetics N.V., Belgium
Information provided by (Responsible Party):
Holger Joswig, Cantonal Hospital of St. Gallen

Brief Summary:

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.

Condition or disease
Subarachnoid Hemorrhage Terson Syndrome CSF-proteines

Detailed Description:

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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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Pathogenesis of Terson Syndrome and the Role of CSF Tau / Amyloid-ß 40 and 42 in Patients With Aneurysmatic Subarachnoid Hemorrhage
Study Start Date : April 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis Bleeding

Group/Cohort
Subarachnoid hemorrhage with and without Terson syndrome
Patients with aneurysmatic subarachnoid hemorrhage with and without Terson syndrome



Primary Outcome Measures :
  1. Intracranial pressure (ICP) in mmH20 [ Time Frame: after insertion of EVD or ICP-probe (between day 0 and 3) ]
    Initial ICP is measured in mmH20 after insertion of EVD with a riser tube or after insertion of an ICP-probe.


Secondary Outcome Measures :
  1. Concentration of CSF-protein phospho-tau [ Time Frame: Day 0, 2, 6 ]
    Concentration of CSF-protein phospho-tau taken from EVD-CSF

  2. Concentration of CSF-protein amyloid-ß 40/42 [ Time Frame: Day 0, 2, 6 ]
    Concentration of CSF-protein phospho-tau taken from EVD-CSF

  3. Delayed cerebral ischemia [ Time Frame: Daily for the duration of hospital stay, an expected average of 3 to 5 weeks ]
    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).

  4. Clinically manifest vasospasm [ Time Frame: Daily for the duration of hospital stay, an expected average of 3 to 5 weeks ]
    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.

  5. Re-bleed [ Time Frame: Daily for the duration of hospital stay, an expected average of 3 to 5 weeks ]
    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).

  6. Surgery for refractory ICP (decompressive hemicraniectomy) [ Time Frame: Daily for the duration of hospital stay, an expected average of 3 to 5 weeks ]
    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.

  7. Necessity of CSF-shunt [ Time Frame: Daily for the duration of hospital stay, an expected average of 3 to 5 weeks ]
    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.

  8. Opthalmologic exam [ Time Frame: Day 0 to 3; before discharge if initial exam negative ]

    Occurrence of Terson syndrome is assessed by fundoscopy with chemically dilated pupils (number of patients of cohort).

    Intraocular pressure (mmHg) is measured.



Other Outcome Measures:
  1. Glasgow-Outcome-Scale-Extended (GOSE) [ Time Frame: initial, 3, 6, 12 months after SAH ]
    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.

  2. Life quality (Euro-Qol-5) [ Time Frame: initial, 3, 6, 12 months after SAH ]
    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.

  3. Neuropsychological deficits [ Time Frame: On day 14 and at 3 and 12 months ]
    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.


Biospecimen Retention:   Samples Without DNA
Cerebrospinal fluid


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with aneurysmatic subarachnoid hemorrhage requiring CSF-diversion and/or intracranial pressure monitoring
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129010


Locations
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Switzerland
Cantonal Hospital St. Gallen
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Holger Joswig
Innogenetics N.V., Belgium
Investigators
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Principal Investigator: Holger Joswig, M.D. Cantonal Hospital St. Gallen, Dept. of Neurosurgery

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Holger Joswig, Dr. med., Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT02129010     History of Changes
Other Study ID Numbers: ICPTS-Sma-2012
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016

Keywords provided by Holger Joswig, Cantonal Hospital of St. Gallen:
subarachnoid hemorrhage
terson syndrome
CSF-proteines
phospho-tau
beta-amyloid

Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Syndrome
Hemorrhage
Disease
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases