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Safety and effectiveness of a prothrombin complex concentrate in approved and off‐label indications
Author(s) -
MarcosJubilar M.,
García Erce J. A.,
MartínezCalle N.,
Páramo J. A.,
Martínez Virto A.,
QuintanaDíaz M.
Publication year - 2019
Publication title -
transfusion medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.471
H-Index - 59
eISSN - 1365-3148
pISSN - 0958-7578
DOI - 10.1111/tme.12621
Subject(s) - medicine , prothrombin complex concentrate , coagulopathy , dosing , off label use , incidence (geometry) , vitamin k antagonist , retrospective cohort study , surgery , warfarin , atrial fibrillation , physics , optics
Summary Objective To evaluate the effectiveness and safety of prothrombin complex concentrates (PCCs) in approved and off‐label indications. Background PCCs are approved for the urgent reversal of vitamin K antagonists (VKAs). Data concerning the efficacy, safety and dosing for off‐label indications are limited, but they are included in massive bleeding protocols. Methods This was a retrospective review of cases treated with four‐factor PCCs (4F‐PCCs) between January 2009 and 2016. Efficacy end‐points include: (i) VKA reversal efficacy assessed by international normalised ratio (INR) normalisation (<1·5) and (ii) clinical efficacy as bleeding cessation and/or decreased number of transfused blood components and 24‐h mortality in bleeding coagulopathy. The safety end‐point is the incidence of thromboembolic events. Results A total of 328 patients were included (51·8% male, median age 78 years old). Indications were as follows: VKA reversal (66·6%), bleeding coagulopathy (30·5%) and direct anticoagulant (DOAC) reversal due to bleeding (2·5%). VKA reversal was effective in 97·1% of patients, and 76·5% demonstrated complete reversal (INR < 1·5); only 34·3% patients needed hemoderivatives. Prior to emergency procedures, PCCs achieved global responses in 83% of patients, with no bleeding complication during intervention. DOAC reversal was effective in 88·9% of patients. Bleeding cessation was associated with the dose administered ( P = 0·002). In coagulopathy bleeding, haemorrhage cessation, established by the International Society of Thrombosis and Haemostais (ISTH) definition, occurred in 56·7% of massive bleeding events and in 42·5% of other coagulopathies; 24‐h mortality was 30%, mainly related to active bleeding. Ten thrombotic episodes were observed (3·1%). Conclusion 4F‐PCC was effective as adjuvant treatment with an acceptable safety profile, not only for the emergent reversal of VKAs but also for refractory coagulopathy associated with major bleeding.