FIBRES Trial

FIBRES was a prospective, multicenter, randomized Phase III study designed to compare the hemostatic efficacy of fibryga® with that of an active control (cryoprecipitate) in patients aged 18 and older who developed acquired fibrinogen deficiency during cardiopulmonary bypass surgery.

A total of 827 patients were randomized to receive either fibryga® (n=415) or the active control (n=412). Of these, 735 patients were included in the primary analysis and safety population, while 725 patients were included in the per-protocol population.

Primary objective

To demonstrate that fibryga® was non-inferior to cryoprecipitate. This was measured by the total number of allogenic blood products (red blood cells, pooled or apheresis platelets and plasma) administered during the first 24 hours after surgery.

Table 1: Total blood products transfused within 24 hours after surgery

fibryga® was also non-inferior to cryoprecipitate for the total number of red blood cells, platelets and plasma transfused within 24 hours after surgery.

Figure 1: Individual blood products used within 24 hours after surgery

Safety

There were 623 AEs in 248 patients in the fibryga^® group and 673 AEs in 264 patients in the cryoprecipitate group. A total of 27 thromboembolic events occurred in 26/372 (7.0%) patients in the fibryga^® group and 39 occurred in 35/363 (9.6%) patients in the cryoprecipitate group. A total of 35 (9.4%) patients in the fibryga^® group and 27 (7.4%) patients in the cryoprecipitate group died. The non-significant difference in mortality may have been related to a higher number of patients in a critical state in the fibryga^® group versus active control group (16.9% vs 10.5%, respectively).

Figure 2: Number of adverse events