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• W2053642019 abstract "Study Objectives: Rapid anticoagulant reversal is essential for subjects on vitamin K antagonists (VKA) that present with acute, major bleeding. The International Normalized Ratio (INR), factor (F) levels (FII, FVII, FIX, and FX) and protein (P) C and PS were assessed pre- and post-administration of PCC-4 or plasma in subjects taking VKAs presenting with major bleeding. Methods: Subjects (aged ≥ 18 years) requiring urgent VKA reversal for acute, major bleeding were randomized (1:1) to receive PCC-4 (containing FII, FVII, FIX, FX, PC and PS; Beriplex P/N, CSL Behring) (N = 98) or plasma (N = 104) in this prospective, randomized phase IIIb trial. Dose was based on baseline INR and subject's weight. Consequently, PCC-4 (reconstituted to 25 IU of FIX/mL) was stratified by baseline INR (2 - <4; 4-6; > 6) into 3 different doses (as randomized): 25 (n = 47), 35 (n = 24), and 50 (n = 27) IU of FIX/kg, respectively. The corresponding plasma doses were: 10 (n = 53), 12 (n = 20) and 15 (n = 31) mL/kg. Per protocol, vitamin K was also administered by slow IV infusion. INR and factor levels (FII, FVII, FIX, FX, PC, PS) were measured pre-infusion (baseline) and up to 24 h after the start of the infusion. Results: No significant differences were detected between groups in the mean baseline INR (Table) . However, at 0.5 h after the start of the infusion, the mean INR in the PCC-4 group was significantly lower than the plasma group for each dose. The INR reversal was most pronounced in the baseline INR > 6 group; the mean INR in the PCC-4 group reduced from 10.6 to 1.5 within 0.5 h of the start of infusion versus INR 10.9 to 3.7 in the plasma group. The difference between groups was still evident at 1 h at all doses, although INR was similar by 24 h post-infusion. Median factor levels at baseline were <50% in both groups with no differences between PCC-4 and plasma groups at any dose (p > 0.05). Factor levels were higher than baseline at 0.5 h after the start of the infusion for both groups (p<0.05); for each PCC-4 dose at 0.5 h, factor levels were > 50% (except for FVII at INR 4-6 and > 6 [≥ 45%] and PS at INR 4-6 [> 48%]), whereas levels were <50% for all plasma doses (except for INR 2 - <4 for FIX [58%] and PC [53%]). Each factor level at 0.5 h was significantly higher after PCC-4 than plasma for each dose (p<0.05). Factor levels were also higher than baseline at 24 h for each dose in both groups (p<0.05).Tabled 1 Conclusion: Marked INR corrections and factor level increases were observed within 0.5 h of the start of PCC-4 infusion, irrespective of dose; these improvements were not observed until much later in the plasma group (> 3 h; data not shown). After 24 h, INRs and factor levels were similar between treatment groups. Therefore, whilst both products achieved INR reversal by 24 h, PCC-4 was more successful in the first hour." @default.
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• W2053642019 date "2012-10-01" @default.
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• W2053642019 title "24 Correction of INR and Coagulation Factor Levels in a Randomized Clinical Trial of Four-Factor Prothrombin Complex Concentrate (PCC-4) Versus Plasma for Urgent Vitamin K Antagonist Reversal" @default.
• W2053642019 doi "https://doi.org/10.1016/j.annemergmed.2012.06.051" @default.
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