NCT04434287

Brief Summary

Outcome of stroke patients admitted to the intensive care unit the intensive care unit (ICU) is poor and haemorrhagic stroke, fixed dilated pupil(s) and GCS \<10 are associated with increased mortality and poor functional outcome. However little is known about the impact of clinical events occuring during the ICU stay (ventilator acquired pneumoniae, shock, dysglycemia....). The objective of this study was to determine the mortality rate and the functional outcomes of stroke patients admitted to ICU and to identify predictors of poor outcome in this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

June 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2020

Completed
Last Updated

August 5, 2020

Status Verified

April 1, 2020

Enrollment Period

17 days

First QC Date

June 4, 2020

Last Update Submit

August 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality

    through ICU hospitalization, an average of one month

Secondary Outcomes (2)

  • Mortality

    At 90 days

  • Functional outcome: Modified Rankin Score

    at hospitalization discharge, an average of three months

Eligibility Criteria

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

All patients with acute stroke admitted to ICU in the Brest Teaching Hospital (Cavale Blanche) BREST (The Brest REgistry of STroke)

You may qualify if:

  • acute stroke
  • ICU admission for acute stroke
  • organ dysfunction : coma, shock, respiratory failure

You may not qualify if:

  • refuse participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

StrokeCritical Illness

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 16, 2020

Study Start

June 12, 2020

Primary Completion

June 29, 2020

Study Completion

June 29, 2020

Last Updated

August 5, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning two year and ending five years following the end study
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations