• Influence of Preop Fibrinogen on Blood in Pediatric Cardiac Surgery

  NCT05525195

  CompletedObservationalUpdated Jul 27, 2023
• Fibrinogen and Bleeding After Cardiac Surgery

  NCT00968045

  CompletedInterventionalPhase 2Updated May 20, 2015
• Kinetics of Plasma Fibrinogen in Cardiac Surgery

  NCT02605330

  CompletedObservationalUpdated Sep 18, 2017
• Fibrinogen Concentrate In Children Cardiac Surgery 2

  NCT03884725

  Unknown statusInterventionalPhase 4Updated Mar 21, 2019
• FIBrinogen REplenishment in Surgery

  NCT03037424

  CompletedInterventionalPhase 3Updated May 14, 2019
• Fibrinogen Concentrate vs Cryoprecipitate

  NCT03014700

  CompletedInterventionalPhase 4Updated May 7, 2019

ClinicalTrials.gov ID

NCT07425600

Lead Sponsor

Centre Hospitalier Universitaire de Saint EtienneOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

150Estimated

Last Update Posted

Apr 22, 2026Actual

Start Date

Nov 1, 2026Estimated

Primary Completion Date

Oct 31, 2028Estimated

Completion Date

Nov 7, 2028Estimated

Official Title

Individualized Dose of Fibrinogen Following Cardiopulmonary Bypass

Brief Summary

Heart surgery is essential for many cardiovascular conditions, but it is a major operation with a significant mortality rate of around 4% in Europe. Among the main complications encountered postoperatively, hemorrhage occurs at a rate of around 8.2% for severe bleeding and 1.6% for massive bleeding.

Hemorrhagic complications are caused by hemostasis disorders attributable to extracorporeal circulation (ECC). Despite recent advances in material design, ECG activates hemostasis, leading to the consumption of various coagulation factors, including fibrinogen, as well as the absorption of fibrinogen by the various components of the circuit. Postoperative hypofibrinogenemia has multiple causes and is correlated with the risk of bleeding and the need for red blood cell transfusions in cardiac surgery under CPB, and therefore indirectly with mortality related to this procedure. The administration of fibrinogen concentrates is the standard treatment; however, the optimal dose to normalize fibrinogen levels and reduce bleeding is unknown.

Good practice recommendations in cardiac surgery suggest administering fibrinogen in cases of bleeding associated with fibrinogen levels below 2 g/L. However, the time required to obtain fibrinogen level results from the laboratory (approximately 1 hour) is not always compatible with the urgency of transfusion needs in these situations. Transfusion optimization strategies have been proposed using viscoelastic tests (ROTEM, Werfen, or Quantra, Stago, for example). The administration of fibrinogen guided by these tests has reduced the need for red blood cell transfusions; however, this strategy increases the cost attributable to fibrinogen because it favors its administration without individualizing the dose to be administered. To date, it is not possible to individualize the dose of fibrinogen to be administered based on baseline fibrinogen levels and kinetics. Developing such an administration strategy would allow for i) faster correction of hypofibrinogenemia and ii) a reduction in associated costs by administering the minimum effective dose.

• Fibrinogen Deficiency in Complex Cardiac Surgery

• Blood samples for PK

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Adult
• Patient undergoing cardiac surgery under cardiopulmonary bypass
• Indication for fibrinogen administration after cardiopulmonary bypass weaning
• Patient affiliated with or entitled to social security coverage
• Patient who has received informed consent about the study

Exclusion Criteria:

• Administration of fibrinogen in the context of massive transfusion
• Contraindication to the administration of the fibrinogen concentrate under study
• Constitutional afibrinogenemia, constitutional dysfibrinogenemia, or any other constitutional diseases related to hemostasis
• Pregnant women, women in labor, breastfeeding women
• Adults subject to legal protection measures (guardianship or curatorship)
• Patients with preoperative anemia < 6 g/dL
• Patients with a life expectancy < 24 hours
• Patients who do not speak French
• Refusal to participate

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Centre Hospitalier Universitaire de Saint EtienneOTHER

Collaborators

Laboratoires LFBUNKNOWN

julien.lanoiselee@chu-st-etienne.fr(0)477120388 ext. +33