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Prothrombin complex concentrate (Beriplex ® P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial
Author(s) -
PABINGER I.,
BRENNER B.,
KALINA U.,
KNAUB S.,
NAGY A.,
OSTERMANN H.
Publication year - 2008
Publication title -
journal of thrombosis and haemostasis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.947
H-Index - 178
eISSN - 1538-7836
pISSN - 1538-7933
DOI - 10.1111/j.1538-7836.2008.02904.x
Subject(s) - medicine , prothrombin complex concentrate , anticoagulant , pulmonary embolism , hemostasis , prospective cohort study , clinical trial , prothrombin time , anesthesia , emergency department , surgery , warfarin , psychiatry , atrial fibrillation
Summary. Background: Prothrombin complex concentrate (PCC) can substantially shorten the time needed to reverse antivitamin K oral anticoagulant therapy (OAT). Objectives. To determine the effectiveness and safety of emergency OAT reversal by a balanced pasteurized nanofiltered PCC (Beriplex ® P/N) containing coagulation factors II, VII, IX, and X, and anticoagulant proteins C and S. Patients and methods: Patients receiving OAT were eligible for this prospective multinational study if their International Normalized Ratio (INR) exceeded 2 and they required either an emergency surgical or urgent invasive diagnostic intervention or INR normalization due to acute bleeding. Stratified 25, 35, or 50 IU kg −1 PCC doses were infused based on initial INR. Study endpoints included INR normalization (≤1.3) by 30 min after PCC infusion and hemostatic efficacy. Results: Forty‐three patients, 26 requiring interventional procedures and 17 experiencing acute bleeding, received PCC infusions at a median rate of 7.5 mL min −1 (188 IU min −1 ). At 30 min thereafter, INR declined to ≤1.3 in 93% of patients. At all postinfusion time points through 48 h, median INR remained between 1.2 and 1.3. Clinical hemostatic efficacy was classified as very good or satisfactory in 42 patients (98%). Prompt and sustained increases in circulating coagulation factors and anticoagulant proteins were observed. One fatal suspected pulmonary embolism in a patient with metastatic cancer was judged to be possibly PCC‐related. Conclusions: PCC treatment serves as an effective rapid hemorrhage control resource in the emergency anticoagulant reversal setting. More widespread availability of PCC is warranted to ensure its benefits in appropriate patients.