NCT03995940

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

June 24, 2019

Status Verified

June 1, 2019

Enrollment Period

6 months

First QC Date

June 21, 2019

Last Update Submit

June 21, 2019

Conditions

Intracranial Hemorrhage, Hypertensive

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with a primary and spontaneous supratentorial ICH

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble University Hospital

Grenoble, 38000, France

RECRUITING

MeSH Terms

Conditions

Intracranial Hemorrhage, Hypertensive

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Catherine Portal

CONTACT

+33.4.76.76.67.29bportal@chu-grenoble.fr

Camille Ducki

CONTACT

ArcPromoteur@chu-grenoble.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2019

First Posted

June 24, 2019

Study Start

April 30, 2019

Primary Completion

November 1, 2019

Study Completion

January 1, 2020

Last Updated

June 24, 2019

Record last verified: 2019-06

Locations

FR(1)