[EngO5-2] Efficacy and safety of fibrinogen concentrate in patients with hemorrhagic shock: a single-center experience
Introduction:
Several guidelines have suggested that administration of fibrinogen concentrate (FC) improves outcomes of massive hemorrhage. But in Japan, administration of FC for acquired fibrinogen deficiencies due to massive hemorrhage is not covered by health insurance. Therefore, since approval of the off-label use of FC by our institutional review board on March 2015, we have administered FC in the patients with hemorrhagic shock. The objective of this study was to evaluate the efficacy and safety of FC for patients with hemorrhagic shock.
Methods:
A retrospective chart review was conducted in patients admitted with hemorrhagic shock who received FC from March 2015 to June 2018.
Result:
The study population comprised 23 patients who were consisted primarily of females (14 [60.9%]) and median age was 71.0 (IQR 49.5 – 77.5, MIN 8, MAX 88) years. Etiologies were multiple trauma (17), postpartum bleeding (4), postoperative bleeding (1), and varices rupture (1). The mean dose of fibrinogen concentrate administered was 3.0g (IQR 3.0 – 3.0, MIN 1, MAX 3). The median initial fibrinogen plasma level was 101.0 mg/dl (IQR 75.5 – 134.5, MIN <30, MAX 482.0), which significantly rose to 210.0 mg/dl (IQR 181.0 – 251.5, MIN 66, MAX407) (P < 0.0001) after administration of FC. Twenty-two patients (95.7%) eventually achieved reversal of coagulopathy and were admitted to our ICU or general ward. The number of patients who survived after 24h was 22 (95.7%), and 20 (87.0%) after 7 days. No adverse events directly associated with FC were observed. There was no symptomatic venous thromboembolism (VTE) in this population. But asymptomatic VTE were detected in 5 patients (21.7%).
Conclusion:
Administration of FC significantly raised fibrinogen levels in patients with hemorrhagic shock. And clinical hemostasis was obtained in almost all patients without serious thrombotic complications.
Several guidelines have suggested that administration of fibrinogen concentrate (FC) improves outcomes of massive hemorrhage. But in Japan, administration of FC for acquired fibrinogen deficiencies due to massive hemorrhage is not covered by health insurance. Therefore, since approval of the off-label use of FC by our institutional review board on March 2015, we have administered FC in the patients with hemorrhagic shock. The objective of this study was to evaluate the efficacy and safety of FC for patients with hemorrhagic shock.
Methods:
A retrospective chart review was conducted in patients admitted with hemorrhagic shock who received FC from March 2015 to June 2018.
Result:
The study population comprised 23 patients who were consisted primarily of females (14 [60.9%]) and median age was 71.0 (IQR 49.5 – 77.5, MIN 8, MAX 88) years. Etiologies were multiple trauma (17), postpartum bleeding (4), postoperative bleeding (1), and varices rupture (1). The mean dose of fibrinogen concentrate administered was 3.0g (IQR 3.0 – 3.0, MIN 1, MAX 3). The median initial fibrinogen plasma level was 101.0 mg/dl (IQR 75.5 – 134.5, MIN <30, MAX 482.0), which significantly rose to 210.0 mg/dl (IQR 181.0 – 251.5, MIN 66, MAX407) (P < 0.0001) after administration of FC. Twenty-two patients (95.7%) eventually achieved reversal of coagulopathy and were admitted to our ICU or general ward. The number of patients who survived after 24h was 22 (95.7%), and 20 (87.0%) after 7 days. No adverse events directly associated with FC were observed. There was no symptomatic venous thromboembolism (VTE) in this population. But asymptomatic VTE were detected in 5 patients (21.7%).
Conclusion:
Administration of FC significantly raised fibrinogen levels in patients with hemorrhagic shock. And clinical hemostasis was obtained in almost all patients without serious thrombotic complications.