Neurological Outcomes of Primary Intracerebral Haemorrhage

Intracranial Hemorrhage, Hypertensive Clinical Trial

— HIP-REA  

Official title:

Neurological Outcomes of Primary Intracerebral Haemorrhage Admitted in Intensive Care Unit at the University Hospital of Grenoble Alpes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03995940
• Other study ID #: 38RC19.029
• Secondary ID: 2019-A00345-52
• Status: Recruiting
• Start date: April 30, 2019
• Est. completion date: January 2020

Study information

• Verified date: June 2019
• Source: University Hospital, Grenoble
• Contact: Catherine Portal
• Phone: +33.4.76.76.67.29
• Email: bportal[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracranial Hemorrhage, Hypertensive
• Intracranial Hemorrhages

Locations

Country	Name	City	State
France	Grenoble University Hospital	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological outcomes	Collection of the Modified Ranking Scale (mRS) at one year by patients phone call or with the medicale file.	One year after the stroke