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Trial record 37 of 195 for:    Hemorrhage AND SAH

Impact of Herniation on WFNS Grading in Spontaneous Subarachnoid Hemorrhage - a SWISS SOS Observational Trial (hWFNS)

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ClinicalTrials.gov Identifier: NCT02304328
Recruitment Status : Active, not recruiting
First Posted : December 1, 2014
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

All patients (≥18 years) with a spontaneous SAH proven by computed tomography (CT), magnetic resonance imaging (MRI) or lumbar puncture will be considered for this trial. Upon presentation to a neurosurgical centre the patients will be treated according to the local protocol. Upon admission the patient is clinically evaluated for occurrence of clinical signs of brain herniation syndromes (anisocoria, bilateral dilated pupils, posturing). Usually first line treatment includes neurological resuscitation (placement external cerebrospinal fluid drainage in case of hydrocephalus, treatment of seizure, and general intensive care measures). Hereafter, the patient is clinically evaluated for a second time. The patients will be graded according to the usual WFNS scale and the modified "herniation WFNS" scale. The whole treatment of the patient will be according to local clinical protocols. Outcome will be measured at six and twelve months by trained investigators who are unaware of clinical data. The primary endpoint is the difference of specificities of the WFNS and hWFNS with respect to poor outcome (mRS 4-6) at 6 months after initial haemorrhage. Given that specificity and sensitivity are negatively correlated, difference in sensitivity will be the second primary outcome.

The null hypothesis to be tested is that the ratio of the true negative rates (specificity) of the hWFNS and WFNS scores is 1.35 i.e. the new score will detect 35% more patients as truly negative (good outcome) as compared to the old score. In addition and because of the negative correlation between specificity and sensitivity we will also test that the ratio of the true positive rate (sensitivity) is not below 0.82 i.e. the new score will not more than 18% less patients as truly positive (poor outcome).


Condition or disease Intervention/treatment
Subarachnoid Hemorrhage Other: Clinical assessment

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of Herniation on WFNS Grading and Outcome in Spontaneous Subarachnoid Hemorrhage - a SWISS SOS Observational Trial
Study Start Date : December 2015
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Hernia

Group/Cohort Intervention/treatment
No clinical signs of brain herniation syndrome
Poor grade (WFNS IV and V) SAH patients without clinical signs of brain herniation syndrome
Other: Clinical assessment
Patients will be clinically assessed whether they present clinical signs of brain herniation syndromes

Clinical signs of brain herniation syndrome
Poor grade (WFNS IV and V) SAH patients with clinical signs of brain herniation syndrome
Other: Clinical assessment
Patients will be clinically assessed whether they present clinical signs of brain herniation syndromes




Primary Outcome Measures :
  1. 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 ]
    Comparison of the two scales (calculation); the basis is the mRS at 6 months


Secondary Outcome Measures :
  1. Composite of dependency and mortality as assessed by the mRS (4-6) [ Time Frame: At 12 months ]
  2. 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 ]
  3. Residential care [ Time Frame: At 6 and 12 months ]
    Institution where 24/7 care is available

  4. Timing of WFNS grading [ Time Frame: Before and after neurological resuscitation, i.e. within 6 hours after admission ]
  5. Recurrent SAH [ Time Frame: At 6 months ]
  6. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients (≥18 years) with a proven spontaneous SAH will be considered for this trial
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)

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): NCT02304328


Locations
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Switzerland
Kantonsspital Aarau
Aarau, Switzerland, 5001
University Hospital Basel
Basel, Switzerland, 4031
Department of Neurosurgery, University Hospital Bern
Bern, Switzerland, 3010
Hôpitaux Universitaires de Genève
Genève, Switzerland, 1211
CHUV Lausanne
Lausanne, Switzerland, 1011
Ospedale Regionale di Lugano - Civico e Italiano
Lugano, Switzerland, 6900
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
Universitätsspital Zürich
Zürich, Switzerland, 8091
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Christian Fung, MD University Hospital Inselspital, Berne

Publications:

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02304328     History of Changes
Other Study ID Numbers: 118/15
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

Keywords provided by University Hospital Inselspital, Berne:
SAH
WFNS
hWFNS
grading

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