A Phase 3, Prospective, Randomized, Double-Blind, Multicenter, Non-Inferiority Study Comparing Two Four-Factor Prothrombin Complex Concentrates for Reversal of …

R Sarode, JN Goldstein, G Simonian, TJ Milling Jr - Blood, 2022 - ashpublications.org
Introduction: The 4-factor prothrombin complex concentrates (4F-PCCs) are very effective in
urgent reversal of vitamin K antagonist (VKA) anticoagulant therapy, including correction of …

[HTML][HTML] Randomized phase IIIb study of rapid vitamin K antagonist reversal in patients requiring an urgent surgical procedure: Four-factor prothrombin complex …

MA Refaai, JN Goldstein, TJ Milling Jr, B Lewis… - Blood, 2013 - Elsevier
Background A four-factor prothrombin complex concentrate (4F-PCC) has recently been
approved by the FDA for urgent vitamin K antagonist (VKA, eg warfarin) reversal in patients …

Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a …

JN Goldstein, MA Refaai, TJ Milling, B Lewis… - The Lancet, 2015 - thelancet.com
Background Rapid reversal of vitamin K antagonist (VKA)-induced anticoagulation is often
necessary for patients needing urgent surgical or invasive procedures. The optimum means …

[PDF][PDF] Efficacy and Safety of a Four-Factor Prothrombin Complex Concentrate (4F-PCC) in Patients on Vitamin K Antagonists Presenting with Major Bleeding: A …

R Sarode, TJ Milling Jr, MA Refaai, A Mangione… - Citeseer
Background—Patients experiencing major bleeding while taking vitamin K antagonists
(VKAs) require rapid VKA reversal. We performed a prospective clinical trial to compare non …

Safety and effectiveness of a four-factor prothrombin complex concentrate for vitamin K antagonist reversal following a fixed-dose strategy

CS Jiménez, JA Romero-Garrido… - European Journal of …, 2021 - ejhp.bmj.com
Objectives Early reversal of anticoagulation improves outcomes in major bleeding and
emergency surgery. To reverse vitamin K antagonists (VKA), vitamin K in addition to …

[HTML][HTML] Efficacy and safety of a 4-factor prothrombin complex concentrate for rapid vitamin K antagonist reversal in Japanese patients presenting with major bleeding …

S Kushimoto, T Fukuoka, A Kimura, K Toyoda… - International journal of …, 2017 - Springer
Rapid vitamin K antagonist (VKA) reversal is required in patients experiencing major
bleeding or requiring urgent surgery. Four-factor prothrombin complex concentrate (4F-PCC; …

[HTML][HTML] Emergency reversal of anticoagulation with vitamin K antagonists with 3-factor prothrombin complex concentrates in patients with major bleeding

D Imberti, A Magnacavallo, F Dentali… - Journal of thrombosis …, 2013 - Springer
Major bleeding is a serious and potentially fatal complication of treatment with vitamin K
antagonists (VKAs). Prothrombin complex concentrates (PCCs) can substantially shorten the …

Four factor prothrombin complex concentrate (human): review of the pharmacology and clinical application for vitamin K antagonist reversal

TN Kinard, R Sarode - Expert Review of Cardiovascular Therapy, 2014 - Taylor & Francis
Vitamin K antagonists (VKAs) have been used for decades for the treatment and prophylaxis
of thromboembolic events. Due to their wide range of therapeutic indications, they are the …

24 Correction of INR and Coagulation Factor Levels in a Randomized Clinical Trial of Four-Factor Prothrombin Complex Concentrate (PCC-4) Versus Plasma for …

MA Refaai, JN Goldstein, TJ Milling… - Annals of …, 2012 - annemergmed.com
Study Objectives: Rapid anticoagulant reversal is essential for subjects on vitamin K
antagonists (VKA) that present with acute, major bleeding. The International Normalized …

Safety of a Four‐factor Prothrombin Complex Concentrate Versus Plasma for Vitamin K Antagonist Reversal: An Integrated Analysis of Two Phase III b Clinical Trials

TJ Milling Jr, MA Refaai, R Sarode… - Academic …, 2016 - Wiley Online Library
Objectives Clinicians often need to rapidly reverse vitamin K antagonists (VKA s) in the
setting of major hemorrhage or urgent need for surgery. Little is known about the safety …