Why the study?
Does prothrombin complex concentrate effectively and safely reverse prolonged INR in high-risk patients on warfarin?
Does prothrombin complex concentrate effectively and safely reverse prolonged INR in high-risk patients on warfarin?
A single injection of prothrombin complex concentrate effectively and safely reverses prolonged INR in high-risk patients on warfarin within 30 minutes.
May support PCC consideration for urgent warfarin reversal; hypothesis-generating and requires RCT confirmation of safety.
We evaluated the effectiveness and safety of prothrombin complex concentrate (PCC) in urgent warfarin reversal in Iran. This is a nonrandomized, pre-post intervention study. Thirty-seven high-risk patients with prolonged international normalized ratio ([INR] >8) or with bleeding symptoms were enrolled in this study. Prothrombin complex concentrate was infused with a dose of 22.4 ± 11.2 IU/kg. The INR was measured 30 minutes postinfusion. Mean age of the participants was 63.9 ± 14.5 (22-89 years). After 30 minutes of PCC injection, INR reversed to <3.5 in 31 patients (84%) in whom 12 patients achieved INR 1.5 to 2.5, and 19 patients achieved INR 2.5 to 3.5. Bleeding symptoms were subsided during 0.5 hour after PCC infusion in patients with hemorrhagic symptoms. Not any adverse reaction was observed in patients during 3-month follow-up. Our experience in use of single injection of PCC in high-risk patients with prolonged INR or with bleeding symptoms was successful without any complication.
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Haghpanah et al. (2012) studied this question.
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