NCT07425600: INDOFIB

Individualized Dose of Fibrinogen Following Cardiopulmonary Bypass

Not yet recruiting Last updated 23 February 2026

What this trial tests

trial testing Blood samples for PK in Fibrinogen Deficiency in Complex Cardiac Surgery in 150 participants. Not yet recruiting.

Timeline

1 March 2026

Primary endpoint
7 September 2028

7 September 2028

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Saint Etienne
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	150
Start date	1 March 2026
Primary completion	7 September 2028
Estimated completion	7 September 2028
Sites	2 locations across France

Drugs / interventions tested

• Blood samples for PK — full drug profile →

Conditions studied

• Fibrinogen Deficiency in Complex Cardiac Surgery — all drugs for Fibrinogen Deficiency in Complex Cardiac Surgery →

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Who can join

18 and older, any sex, with Fibrinogen Deficiency in Complex Cardiac Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.