Observational Study of Patients With Subarachnoid Hemorrhage

ID: NCT02890004
Status: Recruiting
Phase: N/A
Start Date: February 16, 2017
First Submitted: August 24, 2016
Last Updated: February 22, 2018
Results: N/A
Sponsors & Collaborators: Hospices Civils de Lyon
Location: France
Conditions: Subarachnoid Hemorrhage
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Study Description

Brief Summary

This prospective, observational study aim to identify :

- Prognostic factor of patients with subarachnoid haemorrhage in neuro intensive care unit

- The impact of standard therapeutic used (surgery, embolization ; medical treatment of vasospasm ; treatment of complications like hyponatremia, stress myocardiopathy, …)

Detailed Description

Condition or disease Intervention/treatment Phase

Subarachnoid Hemorrhage

N/A

Tracking Information

First Submitted DateAugust 24, 2016
Last Update Posted DateFebruary 22, 2018
Actual Start DateFebruary 16, 2017
Anticipated Completion DateMarch 16, 2020
Actual Primary Completion DateMarch 16, 2020
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Survival [Time Frame: at day 0]

  • Survival [Time Frame: at 6 months]

  • Survival [Time Frame: at 12 months]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Neurological outcome with the Glasgow Coma Scale (GCS) score [Time Frame: at day 0]

  • Neurological outcome with the Glasgow Coma Scale (GCS) score [Time Frame: at 6 months]

  • Neurological outcome with the Glasgow Coma Scale (GCS) score [Time Frame: at 12 months]

  • Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score [Time Frame: at day 0]

  • Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score [Time Frame: at 6 months]

  • Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score [Time Frame: at 12 months]

  • Brain lesions with MRI [Time Frame: at day 0]

  • Brain lesions with MRI [Time Frame: at 6 months]

  • Brain lesions with MRI [Time Frame: at 12 months]

  • delay of apparition of hyponatremia [Time Frame: on alternte days after Day 0]

    Natremia in standard blood sample, Natremia is routinelly evaluated on alternte days, and more if required.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleObservational Study of Patients With Subarachnoid Hemorrhage
Official TitleA Prospective, Observational Registry of Patient With Subarachnoid Hemorrhage in Neurocritical Care Unit
Brief Summary

This prospective, observational study aim to identify :

- Prognostic factor of patients with subarachnoid haemorrhage in neuro intensive care unit

- The impact of standard therapeutic used (surgery, embolization ; medical treatment of vasospasm ; treatment of complications like hyponatremia, stress myocardiopathy, …)

Detailed Description

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
1000
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Subarachnoid Hemorrhage
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study PopulationAll patients admitted to the unit of investigator with subarachnoid hemorrhage, whatever the etiology, is included in their prospective registry
Intervention
Not Available
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Recruiting
Enrollment1000
Completion DateMarch 16, 2020
Eligibility Criteria: Inclusion Criteria:
- Subarachnoid hemorrhage

Exclusion Criteria:
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
France

Administrative Information

NCT Number:NCT02890004
Other Study ID Numbers
69HCL16_0561
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Hospices Civils de Lyon
Collaborators
Not Available
Investigators
Principal Investigator
Frédéric DAILLER, MD
Service de réanimation neurologique Hospices Civils de Lyon