(P-HC-7) A Real-World, Retrospective, Observational Study of Fibrinogen Concentrate in Patients With Acute Gastrointestinal Hemorrhage and Fibrinogen Deficiency: Sub-Analysis of the FORMA-10 Study

Gastrointestinal (GI) bleeding is a leading cause of hospital and intensive care unit admissions globally. In the United States the incidence of GI bleeding is increasing, highlighting the importance of available treatment options. During GI bleeding, low fibrinogen levels or acquired fibrinogen deficiency can occur due to hemodilution and loss of clotting factors, resulting in poor patient outcomes. Fibrinogen deficiency can be corrected using an external fibrinogen source, such as fibrinogen concentrate (FC). The aim of this analysis was to determine the real-world efficacy and safety of FC administered on-demand to patients with GI bleeding from the FORMA-10 study.

Study

Design/Methods:

FORMA-10 (NCT04106895) was an observational, retrospective, non-interventional study evaluating real-world use of FC (Fibryga®, Octapharma) for the on-demand treatment of bleeding and for surgical prophylaxis. The study included 200 patients with fibrinogen deficiency who received FC from December 2017 to February 2020 in 6 regional study centers. FC was available on a temporary agreement with the local regional authority ahead of European approval, and administered on a named-patient basis. The primary endpoint was the indication and dose for FC use; the secondary endpoint was treatment success (defined as complete cessation of bleeding or < 20.0% decrease in hemoglobin for on-demand treatment for non‑surgical bleeding episodes). For this analysis, data on patients with non-surgical GI bleeding from FORMA-10 were examined.

Results/Findings:

A total of 21 patients from 2 centers who received FC for on-demand treatment of non‑surgical, acute gastrointestinal hemorrhage in the FORMA-10 study were included in this analysis. All patients, including 16 males and 5 females, were aged ≥ 18 years, with a mean±SD age of 63.5±12.4 years and a mean weight of 81.3±21.1 kg. Among these patients, 17 (81.0%) received concomitant medication, with 6 (35.3%) receiving tranexamic acid. Mean±SD plasma fibrinogen level at baseline (n=16 reported) was 1.3±0.6 g/L (Figure A). The mean±SD initial dose of FC administered was 2.2±0.8 g or 27.5±11.2 mg/kg (n=16 reported) and the mean total dose was 2.7±1.6 g or 33.6±19.8 mg/kg (n=16 reported). Most patients (n=17; 81.0%) received 1 infusion of FC and 4 patients (19.0%) received 2 infusions. After a mean±SD of 12.0±6.9 hours following the first infusion of FC, the mean plasma fibrinogen level (n=10 reported) increased to 2.1±0.4 g/L. Treatment with FC was rated ‘success’ in 18/21 (85.7%) patients. No adverse drug reactions were reported.

Conclusions:

This real-world data shows that FC was successful for on-demand treatment of non‑surgical GI bleeding, with a favorable safety profile. These findings provide valuable insights to aid clinicians in making informed decisions regarding the use of FC for the management of GI bleeding.