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Link to original content: https://pubmed.ncbi.nlm.nih.gov/18208533
Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial - PubMed Skip to main page content
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Clinical Trial
. 2008 Apr;6(4):622-31.
doi: 10.1111/j.1538-7836.2008.02904.x. Epub 2008 Jan 15.

Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial

I Pabinger  1 , B Brenner, U Kalina, S Knaub, A Nagy, H Ostermann; Beriplex P/N Anticoagulation Reversal Study Group
Collaborators, Affiliations
Free article
Clinical Trial

Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial

I Pabinger et al. J Thromb Haemost. 2008 Apr.
Free article

Abstract

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.

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