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Neurological Outcomes of Primary Intracerebral Haemorrhage (HIP-REA)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995940
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
The main objective of this study is to determine the one-year neurological outcome of patients admitted to an intensive care unit (ICU) for a primary and spontaneous supratentorial intracerebral hemorrhages (ICH).

Condition or disease
Intracranial Hemorrhage, Hypertensive

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

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Neurological Outcomes of Primary Intracerebral Haemorrhage Admitted in Intensive Care Unit at the University Hospital of Grenoble Alpes
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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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
Adult patients with a primary and spontaneous supratentorial ICH
Criteria

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

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): NCT03995940


Contacts
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Contact: Catherine Portal +33.4.76.76.67.29 bportal@chu-grenoble.fr
Contact: Camille Ducki ArcPromoteur@chu-grenoble.fr

Locations
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France
Grenoble University Hospital Recruiting
Grenoble, France, 38000
Contact: Pierluigi Banco, MD    +33.4.76.76.67.29    pbanco@chu-grenoble.fr   
Principal Investigator: Pierluigi Banco, MD         
Sub-Investigator: Samuel Bersinger, MD         
Sponsors and Collaborators
University Hospital, Grenoble
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03995940    
Other Study ID Numbers: 38RC19.029
2019-A00345-52 ( Other Identifier: ID RCB )
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Intracranial Hemorrhages
Intracranial Hemorrhage, Hypertensive
Hemorrhage
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases