What is the clinical evidence from this study?

Study design: Review. Population: Warfarin-induced hemorrhage. Intervention: Warfarin reversal therapies (PCC, FFP, Vitamin K, rFVIIa).

January 1, 2011Open Access

Reversal of Warfarin-Induced Hemorrhage in the Emergency Department

Key Result

Four Factor Prothrombin Complex Concentrate is the most effective method for rapid reversal of warfarin-induced hemorrhage, though Three Factor PCC with vitamin K and rFVIIa is recommended when unavailable.

Structured PICO

What is the optimal therapy for rapid reversal of warfarin-induced hemorrhage in the emergency department?

Population

Patients presenting to the emergency department with warfarin-induced hemorrhage or overanticoagulation.

Intervention

Warfarin reversal therapies including Four-Factor Prothrombin Complex Concentrate (4F PCC), Three-Factor PCC (3F PCC), fresh frozen plasma (FFP), recombinant Factor VIIa (rFVIIa), Factor Eight Inhibitory Bypassing Activity (FEIBA), and vitamin K.

Outcome

Rapid reversal of overanticoagulation (normalization of INR) and control of bleeding.

This review highlights that while 4F PCC is the optimal agent for warfarin reversal, US emergency physicians should utilize 3F PCC with vitamin K and rFVIIa/FEIBA for life-threatening bleeds until 4F PCC becomes available.

Limitations

Four Factor PCC is not approved by the FDA for use in the United States.
High cost and short half-life of rFVIIa.
Fresh frozen plasma requires thawing, ABO matching, and large volumes which can cause volume overload or TRALI.

Abstract

Warfarin, an oral vitamin K antagonist, is used to prevent arterial and venous thromboembolism in patients suffering from a multitude of diseases. In 2004, 31 million warfarin prescriptions were dispensed in the United States. Warfarin inhibits the activation of the vitamin K-dependent clotting factors (Factors II, VII, IX, and X) and regulatory proteins (proteins C, S, and Z). It is one of the leading drugs implicated in emergency room visits for adverse drug reactions. Annually the frequency of bleeding complications associated with overanticoagulation is 15% to 20%, with fatal bleeds measuring as high as 1% to 3%. The most effective method of warfarin reversal involves the use of Four Factor Prothrombin Complex Concentrate (PCC), which is widely used throughout Europe but is unavailable in the United States. The current therapies available to emergency room physicians in the United States are fresh frozen plasma, recombinant Factor VIIa (rFVIIa), Factor Eight Inhibitory Bypassing Activity, or Three Factor PCC concomitantly administered with vitamin K. We review the advantages and disadvantages of these therapies and recommend Three Factor PCC with small doses of rFVIIa and with vitamin K in life-threatening situations if Four Factor PCC is unavailable.

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