- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03995940
Neurological Outcomes of Primary Intracerebral Haemorrhage (HIP-REA)
Neurological Outcomes of Primary Intracerebral Haemorrhage Admitted in Intensive Care Unit at the University Hospital of Grenoble Alpes
Study Overview
Status
Conditions
Detailed Description
ICH represent a diagnostic and therapeutic emergency. ICH account for 20% of strokes with a one-year mortality of more than 45% and an uncertain neurological outcome.
For ICH patients, the main initial challenge is to determine the long term neurological outcomes and adapt the therapeutic strategy.
The majority of primary and spontaneous ICH studies involve patients in stroke units.
The study is an observational type 3 research with all the patients admitted in all the University Hospital of Grenoble Alpes ICUs between July 2012 and July 2017 for a primary and spontaneous supratentorial ICH
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Catherine Portal
- Phone Number: +33.4.76.76.67.29
- Email: bportal@chu-grenoble.fr
Study Contact Backup
- Name: Camille Ducki
- Email: ArcPromoteur@chu-grenoble.fr
Study Locations
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-
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Grenoble, France, 38000
- Recruiting
- Grenoble University Hospital
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Contact:
- Pierluigi Banco, MD
- Phone Number: +33.4.76.76.67.29
- Email: pbanco@chu-grenoble.fr
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Principal Investigator:
- Pierluigi Banco, MD
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Sub-Investigator:
- Samuel Bersinger, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Admission in one of the four University Hospital of Grenoble Alpes ICUs between July 2012 and July 2017 for primary and spontaneous supratentorial ICH.
- Not opposed to participate in a research protocol (asked by phone call)
Exclusion Criteria:
- Pediatric patient
- Infra-tentorials ICH
- No spontaneous ICH (after head trauma)
- Secondary ICH (anevrisum, arteriovenous malformation, tumor, hemorrhagic transformation, vascularitis)
- Persons referred to in Articles L1121-5 to L1121-8 of the french public health code
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurological outcomes
Time Frame: One year after the stroke
|
Collection of the Modified Ranking Scale (mRS) at one year by patients phone call or with the medicale file.
|
One year after the stroke
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC19.029
- 2019-A00345-52 (Other Identifier: ID RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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