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NCT Number: NCT02129010

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.

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Key information

Conditions

Subarachnoid Hemorrhage Brain Diseases CSF-proteines Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Terson Syndrome Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cantonal Hospital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Holger Joswig

Other

Collaborators

  • Innogenetics N.V., Belgium

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 1, 2014
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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