Observational Study About the Use of Fibrinogen in Adult Cardiac Surgery

March 8, 2017 updated by: Société Française d'Anesthésie et de Réanimation

FibCard Study: Observational Study About the Use of Fibrinogen in Adult Cardiac Surgery

Multicenter prospective observational study, involving all adult patients who underwent cardiac surgery with extracorporeal circulation

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patient that underwent a cardiac surgery with extracorporeal circulation.

Description

Inclusion Criteria:

  • Patient over the age of 18 that underwent a cardiac surgery with extracorporeal circulation.
  • Patient who agreed to participate in the study.

Exclusion Criteria:

  • Patient under the age of 18.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The international recommendations published by ESA in 2016
Time Frame: 13 Months
Review the concordance between the presence / absence of indication (according to the international recommendations published by ESA in 2016) and the prescription / non-prescription of fibrinogen concentrates
13 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société Française d'Anesthésie et de Réanimation

Collaborators

Keyrus Biopharma

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 (ANTICIPATED)

March 1, 2017

Primary Completion (ANTICIPATED)

April 1, 2018

Study Completion (ANTICIPATED)

April 1, 2018

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 8, 2017

First Posted (ACTUAL)

March 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2017

Last Update Submitted That Met QC Criteria

March 8, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • FibCard-N°RCB : 2016-A01995-46

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.

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