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NCT03944382 Clinical Trial

What Are the Effects of Fibrinogen Concentrate Administration on Biological Parameters

Hemorrhage Clinical Trial

— Fibri_retro  

Official title:
What Are the Effects of Fibrinogen Concentrate Administration on Biological Parameters

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03944382
Other study ID # Fibri_retro
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2017

Study information
Verified date February 2020
Source Erasme University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- all patient who received fibrinogen concentrate

Exclusion Criteria:

- none

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Erasme University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Evolution of fibrinogen 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 one day
Primary Evolution of FIBTEM A5® FIBTEM A5® 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 one day
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