What Are the Effects of Fibrinogen Concentrate Administration on Biological Parameters (Fibri_retro)
February 26, 2020 updated by: Erasme University Hospital
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
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
125
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
all patient who received fibrinogen concentrate
Description
Inclusion Criteria:
- all patient who received fibrinogen concentrate
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
one day
|
|
Evolution of FIBTEM A5®
Time Frame: one day
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Olivier DURANTEAU, Trainee, Erasme UH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
December 31, 2017
Study Completion (Actual)
December 31, 2017
Study Registration Dates
First Submitted
February 25, 2019
First Submitted That Met QC Criteria
May 8, 2019
First Posted (Actual)
May 9, 2019
Study Record Updates
Last Update Posted (Actual)
February 28, 2020
Last Update Submitted That Met QC Criteria
February 26, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fibri_retro
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.