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Observational Study About the Use of Fibrinogen in Adult Cardiac Surgery

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: NCT03075774
Recruitment Status : Unknown
Verified March 2017 by Société Française d'Anesthésie et de Réanimation.
Recruitment status was:  Not yet recruiting
First Posted : March 9, 2017
Last Update Posted : March 9, 2017
Sponsor:
Collaborator:
Keyrus Biopharma
Information provided by (Responsible Party):
Société Française d'Anesthésie et de Réanimation

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

Condition or disease
Cardiac Surgery Extracorporeal Circulation Fibrinogen

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: FibCard Study: Observational Study About the Use of Fibrinogen in Adult Cardiac Surgery
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patient that underwent a cardiac surgery with extracorporeal circulation.
Criteria

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.

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): NCT03075774


Contacts
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Contact: Longrois Dan, Pr dan.longrois@aphp.fr

Sponsors and Collaborators
Société Française d'Anesthésie et de Réanimation
Keyrus Biopharma
Additional Information:

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Responsible Party: Société Française d'Anesthésie et de Réanimation
ClinicalTrials.gov Identifier: NCT03075774    
Other Study ID Numbers: FibCard-N°RCB : 2016-A01995-46
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No