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Predictors of Hypofibrinogenemia in Severe Trauma

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT03020849
Collaborator
(none)
1,038
Enrollment
2
Locations
49.9
Duration (Months)
519
Patients Per Site
10.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this retrospective and prospective study, the aim is to determine a score for predicting a fibrinogen <1.5g/L (corresponding to European threshold of Directors recommendations of fibrinogen concentrates)

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1038 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Can we Define a Clinical Score for Predicting of Hypofibrinogenemia in Severe Trauma
    Study Start Date :
    Jan 1, 2011
    Actual Primary Completion Date :
    Mar 1, 2015
    Actual Study Completion Date :
    Mar 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. rate of fibrinogen in blood sample at hospitalisation [day 0 (at hospitalisation)]

      This fibrinogen rate is correlated to pre-hospital and admission clinical parameters (trauma type, physiologic status, treatments administered, biologic checkup) to predict fibrinogenemia at hospitalisation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age > 18

    • severe trauma

    Exclusion Criteria:
    • age <18

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HEH - Hospices Civils de Lyon Lyon France 69003
    2 CHLS, Hospices Civils de Lyon Pierre-Bénite France 69495

    Sponsors and Collaborators

    • Hospices Civils de Lyon

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospices Civils de Lyon
    ClinicalTrials.gov Identifier:
    NCT03020849
    Other Study ID Numbers:
    • 69HCL17_0015
    First Posted:
    Jan 13, 2017
    Last Update Posted:
    Jul 28, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Hospices Civils de Lyon
    hypofibrinogenemia
    prediction score
    severe trauma
    Additional relevant MeSH terms:
    Wounds and Injuries

    Study Results

    No Results Posted as of Jul 28, 2017