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ACP Journal Club |15 April 2014

4F-PCC was noninferior to plasma in patients with acute major bleeding who needed urgent VKA reversal

Eddy Lang, MD

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Sarode R, Milling TJ Jr, Refaai MA, et al. Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding: a randomized, plasma-controlled, phase IIIb study. Circulation. 2013;128:1234-43. 23935011

Emergency Med:

Cardiology:

Hematol/Thrombo:

In patients with acute major bleeding who need urgent vitamin K antagonist (VKA) reversal, what is the relative efficacy of 4-factor prothrombin complex concentrate (4F-PCC) and plasma?
Randomized controlled trial. ClinicalTrials.gov NCT00708435.
Unclear allocation concealment.*
Blinded* (assessors of hemostatic outcomes and serious adverse events of interest to the Data Safety Monitoring Board).
24 hours from start of treatment.
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Lang E. 4F-PCC was noninferior to plasma in patients with acute major bleeding who needed urgent VKA reversal. Ann Intern Med. ;160:JC6. doi: 10.7326/0003-4819-160-8-201404150-02006

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Published: Ann Intern Med. 2014;160(8):JC6.

DOI: 10.7326/0003-4819-160-8-201404150-02006

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Journal Club
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Cardiology, Emergency Medicine, Endocrine and Metabolism, Fluid and Electrolyte Disorders, Hematology/Oncology.

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