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CompletedNCT02894034GAINEUpdated Jun 12, 2026

Is the Measured Diameter of the Optic Nerve Sheath by Cerebral Scan in Patients With Early-phase Meningeal Hemorrhage, Due to a Ruptured Aneurysm, a Prognostic 6-month Mortality Factor ?

An observational study in Subarachnoid Hemorrhage, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
114
Ages
18 Years and older
Sex
All
01

Study summary

Sub Arachnoid Hemorrhage (SAH) is a public health concern because of its high incidence (7/100 000 inhab.), its mortality rate (25%), and its morbidity rate (50%).

Read the detailed description

Sub Arachnoid Hemorrhage (SAH) is a public health concern because of its high incidence (7/100 000 inhab.), its mortality rate (25%), and its morbidity rate (50%).

Prognostic tools are indispensable in guiding and optimizing the care of these patients.

Some diagnostic factors have been identified (e.g. age, comorbidities, ACSOS , GCS, ICP, occurrence of complications) as well as some classification schemes used for grading seriousness of the disease (Hunt and Hess, World Federation of NeuroSurgery).

A tool that is simple, reliable, reproducible, non costly, non invasive, and simple to perform (including remote methods and without changing planned patient care) would be ideal.

The measurement of the Optic Nerve Sheath Diameter (ONSD,) correlated by MRI and ultrasound in previous studies, with intra-cranial pressure (ICP: a fundamental prognostic factor for SAH) could be one of these tools.

This measurement, previously demonstrated using ultrasound, could be carried out at the time of the patient's initial cerebral scan.

In practice, at admission each patient undergoes a cerebral CT scan much more often than an ultrasound (faster, less costly, less technical training required).

Two preliminary studies seem to suggest that this measurement of ONSD on CTc is a predictive factor for morbi-morbidity in patients having serious traumatic skull fractures.The measurement is reliable, reproducible, non invasive, and non costly, with good sensitivity and specificity.

Proving that it is also applicable to SAH could be particularly useful.

02

Conditions studied

  • Subarachnoid Hemorrhage

Keywords

  • optic nerve sheath
  • meningeal hemorrhage
  • early phase
  • prognostic
03

In context

Subarachnoid Hemorrhage

509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.

This study's enrollment of 114 is close to the median of 117 across 226 observational studies indexed under Subarachnoid Hemorrhage.

Browse Subarachnoid Hemorrhage studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient admitted to the Neurosurgical Urgent Care Unit for SAH following a ruputred aneurysm

Inclusion criteria

  • Patients 18 years or older
  • Patient admitted to the Neurosurgical Urgent Care Unit for SAH following a ruptured aneurysm
  • Patients or one of their loved ones providing written informed consent
  • Patients with healthcare coverage

Exclusion criteria

Exclusion Criteria:

  • Unavailability of a CTc in the initial phase (within the first 12 hours) or absence of 1-mm slices from the scan
  • Trauma to the optic globe or optic nerve pathology
  • Preexisting anomalies of ICP or history of neurosurgical cerebral pathologies
  • SAH of non aneurysm origin (e.g. arterio-venous malformation (AVM), tumor, trauma, sepsis)
  • Patients under legal protection
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
114 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. patient survival

    patient survival

    Time frame: month 6

07

Study locations

1 site
  • CHU Amiens
    Amiens, 80054, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02894034
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Sep 9, 2016
Start date
Aug 21, 2013
Primary completion
Aug 19, 2022
Completion
Aug 19, 2022
Last update
Jun 12, 2026

Study contacts

Patrick JEANJEAN, MD
principal investigator · CHU Amiens
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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