Neurological Outcomes of Primary Intracerebral Haemorrhage

• Conditions: Intracranial Hemorrhage, Hypertensive

• Registration Number: NCT03995940
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2019-04-30
• Status Verified: 2019-06
• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-21
• Last Update Submitted: 2019-06-21
• Study First Posted: 2019-06-24
• Last Update Posted: 2019-06-24
• Primary Completion: 2019-11
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurological outcomes	One year after the stroke	Collection of the Modified Ranking Scale (mRS) at one year by patients phone call or with the medicale file.

Trial Locations

Locations (1)

Grenoble University Hospital; 🇫🇷 Grenoble, France