Original ArticleIndividualized dosing regimen for prothrombin complex concentrate more effective than standard treatment in the reversal of oral anticoagulant therapy: An open, prospective randomized controlled trial
Section snippets
Material
Prothrombin complex concentrate (Cofact®, licensed in the Netherlands under RVG 17060, Sanquin, Amsterdam, The Netherlands) is manufactured from human plasma obtained from selected, voluntary, non-remunerated donors. Each donation has been tested and found negative for HIV 1–2, HBV, HCV, and HTLV I/II and treponema pallidum by serological and/or NAT testing methods. Virus reducing steps are incorporated in the production process, i.e., a solvent detergent virus inactivation step, as well as a
Results
In this open, prospective, randomized, controlled trial, all 93 patients were included in the intention-to-treat analysis. The characteristics of the patients of group A and B were found to be similar in sex, age, bodyweight, body mass index, number of bleedings and interventions, and the initial-INR and target-INR (Table 2).
For reaching the target-INR at 15 min after the first dosage of PCC, a statistically significant difference was found in the number of patients receiving the individualized
Discussion
In this study, a “standard” dosage of 20 ml PCC is compared with an individualized dosing based on the patient's initial-INR, the target-INR and bodyweight. The 20 ml dosage was the volume of PCC that is regularly being used, like in the hospital where the study was performed. Of the patients treated according to the individualized dosing regimen, significantly more patients attained the target-INR 15 min after administration of PCC, i.e., 89% versus 43% of patients treated with a standard dose.
Acknowledgments
The statistical analysis was performed by H.E. Nienhuis; J.C. Drenth contributed to earlier versions of this article.
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