Aim: Hemostatic management of patients on oral anticoagulant therapy with critical bleeding continues to be a major challenge. The present study aimed to validate the efficacy, safety, and optimal dosage of prothrombin complex concentrate for rapidly normalizing elevated international normalized ratio (INR) values and achieving control of hemorrhage at an emergency department in Japan. Methods: We retrospectively collected data from all patients who were treated with PCC at our emergency department between January 2013 and September 2014. We used a commercially available prothrombin complex concentrate. Results: Fifteen patients (male / female, 7/8; average, 71.4 years) received prothrombin complex concentrate (14 for bleeding, including trauma-related bleeding, and one for invasive intervention) without complications. All but one patient received warfarin and the INR value declined in all patients with 500 IU (average, 8.98 IU/kg) prothrombin complex concentrate (average INR value before and after treatment: 2.20 versus 1.26). Although two patients died because of multiple organ failure, a relatively satisfactory hemostatic response was obtained in at least 11/15 patients. However, patients with a baseline INR value above 2.5 never achieved an optimal response (INR value < 1.35). Conclusion: A single dose of 500 IU prothrombin complex concentrate is insufficient for normalization of INR value, especially in patients with prolonged INR values. Administration strategies for trauma, the ideal dose (e.g., higher than 500 IU/patient), target optimal INR values, as well as the confirmation of safety should be addressed in the future. Further clinical trials are warranted to confirm this preliminary report.
Aim: Hemostatic management of patients on oral anticoagulant therapy with critical bleeding continues to be a major challenge. The present study aimed to validate the efficacy, safety, and optimal dosage of prothrombin complex concentrate for rapidly normalizing elevated international normalized ratio (INR) values and achieving control of hemorrhage at an emergency department in Japan. Methods: We retrospectively collected data from all patients who were treated with PCC at our emergency department between January 2013 and September 2014. We used a commercially available prothrombin complex concentrate. Results: Fifteen patients (male / female, 7/8; average, 71.4 years) received prothrombin complex concentrate (14 for bleeding, including trauma-related bleeding, and one for invasive intervention) without complications. All but one patient received warfarin and the INR value declined in all patients with 500 IU (average, 8.98 IU/kg) prothrombin complex concentrate (average INR value before and after treatment: 2.20 versus 1.26). Although two patients died because of multiple organ failure, a relatively satisfactory hemostatic response was obtained in at least 11/15 patients. However, patients with a baseline INR value above 2.5 never achieved an optimal response (INR value < 1.35). Conclusion: A single dose of 500 IU prothrombin complex concentrate is insufficient for normalization of INR value, especially in patients with prolonged INR values. Administration strategies for trauma, the ideal dose (e.g., higher than 500 IU/patient), target optimal INR values, as well as the confirmation of safety should be addressed in the future. Further clinical trials are warranted to confirm this preliminary report.
Authors: G Palareti; N Leali; S Coccheri; M Poggi; C Manotti; A D'Angelo; V Pengo; N Erba; M Moia; N Ciavarella; G Devoto; M Berrettini; S Musolesi Journal: Lancet Date: 1996-08-17 Impact factor: 79.321
Authors: Ross I Baker; Paul B Coughlin; Alex S Gallus; Paul L Harper; Hatem H Salem; Erica M Wood Journal: Med J Aust Date: 2004-11-01 Impact factor: 7.738