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

Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine
Truman J MillingJoshua N Goldstein

Abstract

Clinicians often need to rapidly reverse vitamin K antagonists (VKAs) in the setting of major hemorrhage or urgent need for surgery. Little is known about the safety profile of the traditional reversal agent, plasma, or the newly approved agent, four-factor prothrombin complex concentrate (4F-PCC), in a randomized setting. This is an integrated analysis of safety data from two clinical trials that evaluated 4F-PCC versus plasma for the treatment of patients requiring rapid VKA reversal for acute major bleeding or prior to an urgent surgical/invasive procedure. This descriptive analysis comprised adverse event (AE) data from two phase IIIb, randomized, controlled trials. The bleeding and surgical studies were performed across 36 and 33 sites, respectively, in nine countries, with the integrated analysis comprising 388 patients (4F-PCC, n = 191; plasma, n = 197) aged ≥ 18 years, who required VKA reversal due to major bleeding or prior to an urgent surgical/invasive procedure. Patients received either 4F-PCC, containing nonactivated factors II, VII, IX, and X and proteins C and S (Beriplex/Kcentra, CSL Behring) or plasma, both dosed according to baseline international normalized ratio and body weight. Patients were also to receive...Continue Reading

References

Jul 11, 2007·Archives of Internal Medicine·Diane K WysowskiLynette Swartz
Sep 1, 2007·Blood Coagulation & Fibrinolysis : an International Journal in Haemostasis and Thrombosis·Reinhard LorenzMonika Barthels
Jan 23, 2008·Journal of Thrombosis and Haemostasis : JTH·I PabingerUNKNOWN Beriplex P/N Anticoagulation Reversal Study Group
Oct 24, 2008·Anesthesiology·Jerrold H LevyWulf Dietrich
Feb 25, 2011·Critical Care : the Official Journal of the Critical Care Forum·Benny SørensenRolf Rossaint
Jun 16, 2011·British Journal of Haematology·David KeelingUNKNOWN British Committee for Standards in Haematology
Nov 25, 2011·The New England Journal of Medicine·Daniel S BudnitzChesley L Richards
May 18, 2012·Transfusion·Suchitra Pandey, Girish N Vyas
Apr 23, 2013·Critical Care : the Official Journal of the Critical Care Forum·Donat R SpahnRolf Rossaint
May 10, 2013·European Journal of Anaesthesiology·Sibylle A Kozek-LangeneckerPiet Wyffels
Sep 17, 2013·British Journal of Haematology·Paula H B Bolton-Maggs, Hannah Cohen

❮ Previous
Next ❯

Citations

May 5, 2017·Journal of Pharmacy Practice·Sanjay MohanMark K Su
Oct 28, 2017·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·Claire VinesMichael A Puskarich
Aug 27, 2017·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Eileen LangstraatShailly Shah
Jun 5, 2019·Expert Review of Hematology·Helmut Ostermann, Christian von Heymann
Jun 14, 2019·ASAIO Journal : a Peer-reviewed Journal of the American Society for Artificial Internal Organs·Douglas L JenningsJean M Connors
Apr 5, 2017·World Journal of Gastroenterology : WJG·Ka-Shing Cheung, Wai K Leung
Dec 4, 2016·Hematology·Sabine Eichinger
Jan 4, 2017·Case Reports in Hematology·Katherine L MarchJennifer D Twilla
Jan 27, 2021·Clinics in Laboratory Medicine·Yunchuan Delores Mo, Meghan Delaney
Jan 22, 2021·Cardiovascular and Interventional Radiology·Mohammed HadiRaman Uberoi
Jan 7, 2021·Digestive Diseases and Sciences·Truman J MillingNeil Sengupta
Jun 22, 2021·TH Open : Companion Journal to Thrombosis and Haemostasis·Paolo Zappulla, Valeria Calvi
Aug 19, 2021·Chinese Journal of Traumatology = Zhonghua Chuang Shang Za Zhi·Yu-Hong Mi, Ming-Ying Xu

❮ Previous
Next ❯

Methods Mentioned

BETA
PCR

Clinical Trials Mentioned

NCT00708435
NCT00803101

Related Concepts

Related Feeds

Blood Clotting Disorders

Thrombophilia includes conditions with increased tendency for excessive blood clotting. Blood clotting occurs when the body has insufficient amounts of specialized proteins that make blood clot and stop bleeding. Here is the latest research on blood clotting disorders.