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SPICE: Stroke Prognosis in Intensive CarE

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France (Other)
Overall Status
Completed
CT.gov ID
NCT03335995
Collaborator
(none)
364
Enrollment
1
Location
37
Actual Duration (Months)
9.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The S.P.I.C.E registry is an investigator-initiated prospective multicenter cohort study which will be conducted in 35 ICUS in the Paris area.The aim of the study is to determine the trajectory of acute stroke patients requiring invasive mechanical ventilation, focusing on functional outcomes at 3 months and 1 year following ICU admission. This project is funded by the French Agence Régionale de Santé (ARS).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    364 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Stroke Prognosis in Intensive CarE - The SPICE Registry
    Actual Study Start Date :
    Oct 18, 2017
    Actual Primary Completion Date :
    Nov 18, 2019
    Actual Study Completion Date :
    Nov 18, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Functional outcome [One year]

      Score on the modified Rankin scale (a disability score that ranges from 0 [no symptoms] to 6 [death]). Patients will be classified as "good outcome" (score of 0-3) or poor outcome (score of 4-6, indicating severe disability or death).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • Age>18 years

    • Acute stroke (acute ischaemic stroke, brain hemorrhage, subarachnoid hemorrhage). The stroke diagnosis date is defined by the date of the initial brain imaging (TDM or MRI).

    • Admitted to ICU within 7 days before or after the diagnosis of stroke.

    • Requiring invasive mechanical ventilation in ICU for more than 24 hours.

    Exclusion criteria:

    • Traumatic causes of stroke

    • Refusal of the patient, or his reliable person, to participate in the study.

    • Privation of liberty by administrative or judicial decision

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bichat Hospital Paris France 75018

    Sponsors and Collaborators

    • Institut National de la Santé Et de la Recherche Médicale, France

    Investigators

    • Study Director: Jean-François TIMSIT, U 1137

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institut National de la Santé Et de la Recherche Médicale, France
    ClinicalTrials.gov Identifier:
    NCT03335995
    Other Study ID Numbers:
    • C17-16
    First Posted:
    Nov 8, 2017
    Last Update Posted:
    Aug 25, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France
    mechanical invasive ventilation
    course of the care
    prognosis
    stroke
    Additional relevant MeSH terms:
    Stroke

    Study Results

    No Results Posted as of Aug 25, 2021