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Predictors of Hypofibrinogenemia in Severe Trauma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03020849
Recruitment Status : Completed
First Posted : January 13, 2017
Last Update Posted : July 28, 2017
Information provided by (Responsible Party):
Hospices Civils de Lyon

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
Severe Trauma

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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 : January 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. rate of fibrinogen in blood sample at hospitalisation [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
severe trauma

Inclusion Criteria:

  • age > 18
  • severe trauma

Exclusion Criteria:

  • age <18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03020849

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HEH - Hospices Civils de Lyon
Lyon, France, 69003
CHLS, Hospices Civils de Lyon
Pierre-Bénite, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon Identifier: NCT03020849     History of Changes
Other Study ID Numbers: 69HCL17_0015
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospices Civils de Lyon:
prediction score
severe trauma
Additional relevant MeSH terms:
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Wounds and Injuries