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Subarachnoid HemorrhageNCT02129010

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

An observational study of Subarachnoid Hemorrhage and Terson Syndrome, run by Holger Joswig at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
120 participants
Where
1 siteSwitzerland
Study dates
Apr 2013to Feb 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients with aneurysmatic subarachnoid hemorrhage requiring CSF-diversion and/or intracranial pressure monitoring

Who may be able to join

  • 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

Who cannot join

  • younger than 18 years
  • other diagnosis such as traumatic or perimesencephalic subarachnoid hemorrhage without an intracranial aneurysm

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Cantonal Hospital St. Gallen

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

About this study

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.
Read the 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.

Keywords
subarachnoid hemorrhage, terson syndrome, CSF-proteines, phospho-tau, beta-amyloid
Medical subject headings
Subarachnoid Hemorrhage, Plaque, Amyloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02129010
Study groupRoleWhat they receive
Subarachnoid hemorrhage with and without Terson syndromePatients with aneurysmatic subarachnoid hemorrhage with and without Terson syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: after insertion of EVD or ICP-probe (between day 0 and 3)

Secondary outcomes (8)

  1. Concentration of CSF-protein phospho-tau

    Concentration of CSF-protein phospho-tau taken from EVD-CSF

    Measured: Day 0, 2, 6

  2. Concentration of CSF-protein amyloid-ß 40/42

    Concentration of CSF-protein phospho-tau taken from EVD-CSF

    Measured: Day 0, 2, 6

  3. 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).

    Measured: Daily for the duration of hospital stay, an expected average of 3 to 5 weeks

  4. 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.

    Measured: Daily for the duration of hospital stay, an expected average of 3 to 5 weeks

  5. 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).

    Measured: Daily for the duration of hospital stay, an expected average of 3 to 5 weeks

  6. 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.

    Measured: Daily for the duration of hospital stay, an expected average of 3 to 5 weeks

  7. 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.

    Measured: Daily for the duration of hospital stay, an expected average of 3 to 5 weeks

  8. Opthalmologic exam

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

    Intraocular pressure (mmHg) is measured.

    Measured: Day 0 to 3; before discharge if initial exam negative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2014 (estimated)
  2. Study startApr 2013
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02129010
Sponsor's protocol ID
ICPTS-Sma-2012
Status last verified
Mar 2016
First submitted
27 Apr 2014
Last updated
8 Mar 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26185328

Questions about this trial

What is this clinical trial studying?

An observational study of Subarachnoid Hemorrhage and Terson Syndrome, run by Holger Joswig at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial pressure (ICP) in mmH20 (time frame: after insertion of EVD or ICP-probe (between day 0 and 3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02129010, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016; AzTrials last refreshed its copy on 8 Nov 2026.

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