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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.
 
ClinicalTrials.gov Identifier: NCT03020849
Recruitment Status : Completed
First Posted : January 13, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date January 10, 2017
First Posted Date January 13, 2017
Last Update Posted Date July 28, 2017
Study Start Date January 2011
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 11, 2017)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03020849 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predictors of Hypofibrinogenemia in Severe Trauma
Official Title Can we Define a Clinical Score for Predicting of Hypofibrinogenemia in Severe Trauma
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)
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population severe trauma
Condition Severe Trauma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 27, 2017)
1038
Original Actual Enrollment
 (submitted: January 11, 2017)
767
Actual Study Completion Date March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • age > 18
  • severe trauma

Exclusion Criteria:

  • age <18
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03020849
Other Study ID Numbers 69HCL17_0015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospices Civils de Lyon
Verification Date January 2017