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Observational Study of Patients With Subarachnoid Hemorrhage (ProReSHA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890004
Recruitment Status : Unknown
Verified February 2018 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : September 7, 2016
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date August 24, 2016
First Posted Date September 7, 2016
Last Update Posted Date February 23, 2018
Actual Study Start Date February 16, 2017
Estimated Primary Completion Date March 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 31, 2016)
  • Survival [ Time Frame: at day 0 ]
  • Survival [ Time Frame: at 6 months ]
  • Survival [ Time Frame: at 12 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 31, 2016)
  • 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 Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study of Patients With Subarachnoid Hemorrhage
Official Title A 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 Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients admitted to the unit of investigator with subarachnoid hemorrhage, whatever the etiology, is included in their prospective registry
Condition Subarachnoid Hemorrhage
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 31, 2016)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 16, 2020
Estimated Primary Completion Date March 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subarachnoid hemorrhage

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02890004
Other Study ID Numbers 69HCL16_0561
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators
Principal Investigator: Frédéric DAILLER, MD Service de réanimation neurologique Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date February 2018