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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

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, …)

Condition or disease
Subarachnoid Hemorrhage

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Observational Registry of Patient With Subarachnoid Hemorrhage in Neurocritical Care Unit
Actual Study Start Date : February 16, 2017
Estimated Primary Completion Date : March 16, 2020
Estimated Study Completion Date : March 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding




Primary Outcome Measures :
  1. Survival [ Time Frame: at day 0 ]
  2. Survival [ Time Frame: at 6 months ]
  3. Survival [ Time Frame: at 12 months ]

Secondary Outcome Measures :
  1. Neurological outcome with the Glasgow Coma Scale (GCS) score [ Time Frame: at day 0 ]
  2. Neurological outcome with the Glasgow Coma Scale (GCS) score [ Time Frame: at 6 months ]
  3. Neurological outcome with the Glasgow Coma Scale (GCS) score [ Time Frame: at 12 months ]
  4. Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score [ Time Frame: at day 0 ]
  5. Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score [ Time Frame: at 6 months ]
  6. Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score [ Time Frame: at 12 months ]
  7. Brain lesions with MRI [ Time Frame: at day 0 ]
  8. Brain lesions with MRI [ Time Frame: at 6 months ]
  9. Brain lesions with MRI [ Time Frame: at 12 months ]
  10. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 admitted to the unit of investigator with subarachnoid hemorrhage, whatever the etiology, is included in their prospective registry
Criteria

Inclusion Criteria:

  • Subarachnoid hemorrhage

Exclusion Criteria:

  • None

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): NCT02890004


Contacts
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Contact: Frédéric DAILLER, MD 4 72 35 75 76 ext +33 frederic.dailler@chu-lyon.fr

Locations
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France
Service de réanimation polyvalente neurologique Hôpital Neurologique HCL Recruiting
Bron, France, 69500
Contact: Frédéric DAILLER, MD    472 35 75 76 ext +33    frederic.dailler@chu-lyon.fr   
Principal Investigator: Frédéric DAILLER, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Frédéric DAILLER, MD Service de réanimation neurologique Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02890004    
Other Study ID Numbers: 69HCL16_0561
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospices Civils de Lyon:
Subarachnoid Hemorrhage
Neurointensive care
Observational registry
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