Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
12 December 2020 |
Main ID: |
NCT02304328 |
Date of registration:
|
18/11/2014 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Impact of Herniation on WFNS Grading in Spontaneous Subarachnoid Hemorrhage - a SWISS SOS Observational Trial
hWFNS |
Scientific title:
|
Impact of Herniation on WFNS Grading and Outcome in Spontaneous Subarachnoid Hemorrhage - a SWISS SOS Observational Trial |
Date of first enrolment:
|
December 2015 |
Target sample size:
|
250 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02304328 |
Study type:
|
Observational |
Study design:
|
|
Phase:
|
|
|
Countries of recruitment
|
Switzerland
| | | | | | | |
Contacts
|
Name:
|
Christian Fung, MD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
University Hospital Inselspital, Berne |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Written informed consent of the patient or consent of patient's next of kin
- Spontaneous SAH
- Age: =18
- Glasgow coma scale (GCS) = 12. In intubated patients the GCS assessment will be
performed after cessation of sedation or if not possible the last GCS score before
intubation will be used
Exclusion Criteria
- SAH due to any other cause or structural abnormality of the brain (trauma, dissection,
arterio-venous malformation, dural arterio-venous fistula)
- Foreseeable difficulties in follow-up due to geographic reasons (e.g., patients living
abroad)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Subarachnoid Hemorrhage
|
Intervention(s)
|
Other: Clinical assessment
|
Primary Outcome(s)
|
Positive predictive value of the WFNS and hWFNS with respect to poor outcome (mRS 4-6) at 6 months after initial hemorrhage
[Time Frame: At 6 months]
|
Secondary Outcome(s)
|
Timing of WFNS grading
[Time Frame: Before and after neurological resuscitation, i.e. within 6 hours after admission]
|
Alternate WFNS Scale (WFNS compared to WFNS IV = GCS 6-12 and WFNS V=GCS 3-5)
[Time Frame: On admission, i.e. at first contact with a neurosurgical Unit, and after neurological resuscitation, i.e. within 6 hours after admission]
|
Recurrent SAH
[Time Frame: At 6 months]
|
Residential care
[Time Frame: At 6 and 12 months]
|
Composite of dependency and mortality as assessed by the mRS (4-6)
[Time Frame: At 12 months]
|
Midline shift in mm measured at the Level of the foramen of Monroe
[Time Frame: On admission, i.e. at first contact with a neurosurgical Unit]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|