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What Are the Effects of Fibrinogen Concentrate Administration on Biological Parameters (Fibri_retro)

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ClinicalTrials.gov Identifier: NCT03944382
Recruitment Status : Completed
First Posted : May 9, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Erasme University Hospital

Brief Summary:
the fibrinogen concentrate are given since 50 years with the dose of 2g for a afibrinogenemia. But this dose has been fixed 40 years ago and from now nobody discuss this quantity. Through this retrospective study the investigators tried to explore the evolution of blood test after a prescription of fibrinogen concentrate

Condition or disease
Hemorrhage

Detailed Description:
the fibrinogen concentrate are given since 50 years with the dose of 2g for a afibrinogenemia. But this dose has been fixed 40 years ago and from now nobody discuss this quantity. Through this retrospective study the investigators tried to explore the evolution of blood test after a prescription of fibrinogen concentrate.

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Study Type : Observational
Actual Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: What Are the Effects of Fibrinogen Concentrate Administration on Biological Parameters
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017



Primary Outcome Measures :
  1. Evolution of fibrinogen [ Time Frame: one day ]
    Fibrinogen was measured before and after a fibrinogen factor transfusion. It will be used to calculate the delta (after - before) and mesure the efficiency of a transfusion

  2. Evolution of Fibtem [ Time Frame: one day ]
    Fibtem was measured before and after a fibrinogen factor transfusion. It will be used to calculate the delta (after - before) and mesure the efficiency of a transfusion



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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
all patient who received fibrinogen concentrate
Criteria

Inclusion Criteria:

  • all patient who received fibrinogen concentrate

Exclusion Criteria:

  • none

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 ClinicalTrials.gov identifier (NCT number): NCT03944382


Sponsors and Collaborators
Erasme University Hospital
Investigators
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Principal Investigator: Olivier DURANTEAU, Trainee Erasme UH

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Responsible Party: Erasme University Hospital
ClinicalTrials.gov Identifier: NCT03944382     History of Changes
Other Study ID Numbers: Fibri_retro
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes