ArticleJournal of thrombosis and thrombolysis2023
Four-factor prothrombin complex concentrate use for on-label versus off-label indications: a retrospective cohort study.
Article in Journal of thrombosis and thrombolysis, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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Who cites it
2 citing papers in PubMed, 4 citations in OpenAlex.
- Long-Term Safety of a Four-Factor Prothrombin Complex Concentrate (Kcentra®/Beriplex® P/N): An Updated Pharmacovigilance Review.Thrombosis and haemostasis · 2025Review
- Efficacy and Safety of Prothrombin complex Concentrate in Patients with Massive Intraoperative Bleeding During non-Cardiac Surgery: A Retrospective Cohort Study.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisArticle
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This study aimed to characterize the utilization of four-factor prothrombin complex concentrate (4F-PCC) at a tertiary academic medical center and evaluate the incidence of thromboembolic events (TEs) and mortality when used in an on-label versus off-label context. All medical records for consecutive patients having received 4F-PCC over 61-months were retrospectively evaluated. On-label indications for 4F-PCC were defined per FDA guidance, with the remaining indications considered off-label. Three hundred sixty-nine 4F-PCC doses were administered to 355 patients, with 46.6% of administrations classified as off-label. On-label and off-label groups demonstrated similar rates of TEs (16.2% vs. 14%). On-label patients receiving repeated administrations of 4F-PCC or with a post-administration INR ≤ 1.5 had a significantly higher incidence of TE. Off-label patients with a prior history of TE were more likely to develop a TE following 4F-PCC administration. Off-label patients also had a significantly higher 30-day mortality relative to on-label patients (29.1% versus 18.3%). In conclusion, in a large cohort of patients, observed rates of off-label 4F-PCC use were high. Underlying prothrombotic risk factors were predictive of TEs in off-label patients. Moreover, patients receiving off-label 4F-PCC demonstrated higher transfusion rates. Overall, our study findings suggest that the utilization of 4F-PCC in an off-label context may convey a significant risk to patients with uncertain clinical benefits.
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