NCT03075774

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

1.1 years

First QC Date

March 6, 2017

Last Update Submit

March 8, 2017

Conditions

Cardiac SurgeryExtracorporeal CirculationFibrinogen

Outcome Measures

Primary Outcomes (1)

  • 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

    13 Months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient that underwent a cardiac surgery with extracorporeal circulation.

You may qualify if:

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

You may not qualify if:

  • Patient under the age of 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 41286643DERIVED

Central Study Contacts

Longrois Dan, Pr

CONTACT

dan.longrois@aphp.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 9, 2017

Study Start

March 1, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

March 9, 2017

Record last verified: 2017-03