Comparison of fresh frozen plasma and prothrombin complex concentrate for the reversal of oral anticoagulants in patients undergoing cardiopulmonary bypass surgery: a randomized study.
Demeyere, R. 1; Gillardin, S. 1; Arnout, J. 2; Strengers, P. F. W. 3,4
[Miscellaneous Article]
Vox Sanguinis.
99(3):251-260, October 2010.
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Background: Fresh frozen plasma (FFP) and prothrombin complex concentrates (PCC) reverse oral anticoagulants. We compared PCC and FFP intraoperative administration in patients undergoing heart surgery with cardiopulmonary bypass (CPB).
Methods: Forty patients [with international normalized ratio (INR) >= 2[middle dot]1] assigned semi-urgent cardiac surgery were randomized to receive either FFP (n = 20) or PCC (n = 20). Prior to CPB, they received either 2 units of FFP or half of the PCC dose calculated according to body weight, initial INR and target INR (<= 1[middle dot]5). After CPB and protamine administration, patients received either another 2 units of FFP or the other half PCC dose. Additional doses were administered if INR was still too high (>= 1[middle dot]5).
Results: Fifteen minutes after CPB, more patients reached INR target with PCC (P = 0[middle dot]007): 7/16 patients vs. 0/15 patients with FFP; there was no difference 1 h after CPB (6/15 patients with PCC vs. 4/15 patients with FFP reached target). Fifteen minutes after CPB, median INR (range) decreased to 1[middle dot]6 (1[middle dot]2-2[middle dot]2) with PCC vs. 2[middle dot]3 (1[middle dot]5-3[middle dot]5) with FFP; 1 h after CPB both groups reached similar values [1[middle dot]6 (1[middle dot]3-2[middle dot]2) with PCC and 1[middle dot]7 (1[middle dot]3-2[middle dot]7) with FFP]. With PCC, less patients needed additional dose (6/20) than with FFP (20/20) (P < 0[middle dot]001). Both groups differed significantly on the course of factor II (P = 0[middle dot]0023) and factor X (P = 0[middle dot]008) over time. Dilution of coagulation factors was maximal at CPB onset. Safety was good for both groups, with only two related oozing cases with FFP.
Conclusion: PCC reverses anticoagulation safely, faster and with less bleeding than FFP.
Copyright (C) 2010 Blackwell Publishing Ltd.