Cardiac SurgeryNCT03075774
Observational Study About the Use of Fibrinogen in Adult Cardiac Surgery
An observational study of Cardiac Surgery and Extracorporeal Circulation, run by Société Française d'Anesthésie et de Réanimation.
Trial summary
Multicenter prospective observational study, involving all adult patients who underwent cardiac surgery with extracorporeal circulation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Extracorporeal Circulation, Fibrinogen
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2017to Apr 2018
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patient that underwent a cardiac surgery with extracorporeal circulation.
Who may be able to join
- Patient over the age of 18 that underwent a cardiac surgery with extracorporeal circulation.
- Patient who agreed to participate in the study.
Who cannot join
- Patient under the age of 18.
Trial locations and contacts
No sites are listed yet.
Longrois Dan, Pr contact
About this study
Official title: 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
- Conditions
- Cardiac Surgery, Extracorporeal Circulation, Fibrinogen
What is being measured
The primary outcome is the main question the study is designed to answer.
The international recommendations published by ESA in 2016
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
Measured: 13 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study startMar 2017 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Société Française d'Anesthésie et de Réanimation
- Sponsor type
- University, hospital or other
- Collaborators
- Keyrus Biopharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075774
- Sponsor's protocol ID
- FibCard-N°RCB : 2016-A01995-46
- Status last verified
- Mar 2017
- First submitted
- 6 Mar 2017
- Last updated
- 9 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Longrois D, Albaladejo P, Bedague D, Ouattara A, Bougle A, Dureau P, Cholley B, Mertes PM, Provenchere S, Robin E, Besch G, Grelet T, Grosjean S, Guinot PG, Rozec B, Rigal JC, Fellahi JL, Colson P; SFAR Research Committee. Compliance with ESAIC guidelines for fibrinogen concentrate prescription in cardiac surgery: a multicentre French cohort study. BMC Anesthesiol. 2025 Nov 24;25(1):594. doi: 10.1186/s12871-025-03347-w.
PubMed 41286643
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FibCard Study: Observational Study About the Use of Fibrinogen in Adult Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03075774
- Acronym / sponsor ID
- FibCard-N°RCB : 2016-A01995-46
- Conditions
- Cardiac Surgery, Extracorporeal Circulation, Fibrinogen
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Société Française d'Anesthésie et de RéanimationUniversity, hospital or other
- Collaborators
- Keyrus Biopharma
- Study start
- Mar 2017 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter prospective observational study, involving all adult patients who underwent cardiac surgery with extracorporeal circulation
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient that underwent a cardiac surgery with extracorporeal circulation.
Key inclusion criteria (2 listed)
- Patient over the age of 18 that underwent a cardiac surgery with extracorporeal circulation.
- Patient who agreed to participate in the study.
Key exclusion criteria (1 listed)
- Patient under the age of 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Derived from this study: PubMed 41286643Longrois D, Albaladejo P, Bedague D, Ouattara A, Bougle A, Dureau P, Cholley B, Mertes PM, Provenchere S, Robin E, Besch G, Grelet T, Grosjean S, Guinot PG, Rozec B, Rigal JC, Fellahi JL, Colson P; SFAR Research Committee. Compliance with ESAIC guidelines for fibrinogen concentrate prescription in cardiac surgery: a multicentre French cohort study. BMC Anesthesiol. 2025 Nov 24;25(1):594. doi: 10.1186/s12871-025-03347-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Longrois Dan, Pr contact
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery and Extracorporeal Circulation, run by Société Française d'Anesthésie et de Réanimation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Longrois Dan, Pr (dan.longrois@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The international recommendations published by ESA in 2016 (time frame: 13 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03075774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.