Use and effectiveness of prothrombin complex concentrate in an emergency department: a review of 15 cases

Abstract

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.

Management of Bleedings and Recurrent Venous Thromboembolism in Patients Receiving Vitamin K Antagonists

“…Инфузию КПК осуществляли при помощи препарата протромплекс 600 («Baxter», Австрия), который содержит в пропорциональном соотношении прокоагулянты: 4 витамин K-зависимых фактора свертывания (II, VII, IX, X) и естественные антикоагулянты: протеин С, антитромбин III и небольшую дозу гепарина, который предупреждает активацию факторов свертывания в процессе приготовления раствора перед введением пациенту. Дозу препарата определяли по исходному МНО, согласно данным японских исследователей [16][17][18] за счет высокой концентрации основных факторов свертывания: в 1 мл КПК в 25-30 раз выше, чем в 1 мл СЗП. После введения КПК кровотечение было остановлено у всех больных и повторного введения препарата не потребовалось.…”

Usefulness of prothrombin complex concentrate for cardiac injury in patients receiving oral anticoagulant therapy

“…However, the most effective dosing regimen for PCC in cardiac injury is still uncertain. According to our recent report, 4 PCC provide rapid (within 30 min) reversal of warfarin-related coagulopathy, but fixed dose of 500 IU may be insufficient for normalization of prolonged INR value. Moreover, the effectiveness of PCC for NOAC has not been confirmed.…”

Use and effectiveness of a two‐level initiation strategy for fixed‐dose prothrombin complex concentrate according to the initial international normalized ratio in an emergency department in Japan

“…In addition, its use is limited to patients with INR over 2. However, rapid normalization of INR during hemostatic management is necessary even in patients with critical bleeding who do not meet the treatment criterion 14,15 . Although PCC has emerged as the preferred option in emergency settings, the optimal dosing strategy, especially in Japanese patients, remains unknown.…”

“…We reported 15 cases of PCC treatment in the emergency department (ED) in 2015 and found that a fixed PCC dose of 500 IU is insufficient in some patients with INR elevation 14 . Conversely, this dose was effective in patients with INR less than 2.5 14 . On the basis of these findings, in October 2014, our institution implemented a two‐level fixed‐dose initiation strategy for PCC featuring an initial dose of 500 or 1,000 IU according to the initial INR (Fig.…”