Observational Study of Patients With Subarachnoid Hemorrhage (ProReSHA)

February 22, 2018 updated by: Hospices Civils de Lyon

A Prospective, Observational Registry of Patient With Subarachnoid Hemorrhage in Neurocritical Care Unit

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, …)

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bron, France, 69500
        • Recruiting
        • Service de réanimation polyvalente neurologique Hôpital Neurologique HCL
        • Contact:
        • Principal Investigator:
          • Frédéric DAILLER, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • Subarachnoid hemorrhage

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: at day 0
at day 0
Survival
Time Frame: at 6 months
at 6 months
Survival
Time Frame: at 12 months
at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological outcome with the Glasgow Coma Scale (GCS) score
Time Frame: at day 0
at day 0
Neurological outcome with the Glasgow Coma Scale (GCS) score
Time Frame: at 6 months
at 6 months
Neurological outcome with the Glasgow Coma Scale (GCS) score
Time Frame: at 12 months
at 12 months
Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score
Time Frame: at day 0
at day 0
Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score
Time Frame: at 6 months
at 6 months
Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score
Time Frame: at 12 months
at 12 months
Brain lesions with MRI
Time Frame: at day 0
at day 0
Brain lesions with MRI
Time Frame: at 6 months
at 6 months
Brain lesions with MRI
Time Frame: at 12 months
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.
on alternte days after Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Frédéric DAILLER, MD, Service de réanimation neurologique Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2017

Primary Completion (Anticipated)

March 16, 2020

Study Completion (Anticipated)

March 16, 2020

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0561

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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