Thrombosis research
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Thrombosis research · Jan 2006
Randomized Controlled TrialIndividualized dosing regimen for prothrombin complex concentrate more effective than standard treatment in the reversal of oral anticoagulant therapy: an open, prospective randomized controlled trial.
Prothrombin Complex Concentrate (PCC) is indicated for the acute reversal of oral anticoagulation therapy. To compare the efficacy of a "standard" dosage of 20 ml PCC equivalent to about 500 IU factor IX (group A), and an "individualized" dosage based on a target-INR of 2.1 or 1.5, the initial-INR and the patient's body weight (group B), we performed an open, prospective, randomized, controlled trial. The in vivo response and in vivo recovery of factor II, VII, IX and X in these patients on oral anticoagulation was determined. ⋯ So, we conclude that for the acute reversal of oral anticoagulant therapy, an "individualized" dosage regimen of PCC based on the target-INR, the initial-INR, and body weight of the patient, is significantly more effective in reaching the target-INR than a "standard" dosage. The in vivo response and in vivo recovery found in this study was higher then in patients with isolated factor deficiencies. This suggests that the pharmacokinetics in patients on oral anticoagulants may be different.