Prothrombin complex concentrate for emergency surgery in patients on oral Xa-inhibitors.

Autor:	Schulman S; Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada; Department of Obstetrics and Gynecology and Perinatal Medicine, The First I.M. Sechenov Moscow State Medical University, Moscow, Russia. Electronic address: schulms@mcmaster.ca., Bhagirath V; Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada., Chan N; Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada., Germini F; Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada; Clinical Epidemiology and Research Center, Istituto di Ricovero e Cura a Carattere Scientifico Humanitas Research Hospital, Milan, Italy., Ikesaka R; Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada., Iorio A; Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada., Mithoowani S; Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada., Weitz JI; Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada., Gross PL; Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada.
Jazyk:	angličtina
Zdroj:	Journal of thrombosis and haemostasis : JTH [J Thromb Haemost] 2024 Oct; Vol. 22 (10), pp. 2761-2766. Date of Electronic Publication: 2024 Jul 11.
DOI:	10.1016/j.jtha.2024.07.002
Abstrakt:	Background: It is uncertain whether prothrombin complex concentrate (PCC) improves hemostasis in patients on treatment with oral factor Xa-inhibitors (XaI) who require emergency surgery. Objectives: To evaluate whether, in patients with therapeutic levels of oral XaI, preoperative PCC prevents excessive bleeding during and after emergency surgery and is not associated with thrombotic complications. Methods: We conducted a prospective cohort study wherein a fixed 2000 IU dose of 4-factor PCC was given to patients taking oral XaI with plasma XaI levels of at least 75 ng/mL before the emergency surgery with an expected blood loss of at least 50 mL. Patients were followed for 30 days. The primary efficacy outcome was the incidence of normal or mildly abnormal surgical hemostasis, as assessed by the surgeon; primary safety outcome was the incidence of thromboembolic events within 7 days. Results: We included 20 patients, of which 50% were female, on apixaban (75%) or rivaroxaban (25%) with median XaI level of 128 ng/mL (range, 77-497 ng/mL). The median duration of surgery was 2 hours 42 minutes (range, 15 minutes to 8 hours 17 minutes). Normal or mildly abnormal hemostasis was observed in 16 patients (80%); 2 patients had moderately abnormal and 2 had severely abnormal hemostasis, 1 each of those was considered due to local or technical factors. There were 4 deaths (20%) secondary to underlying disease and 1 incidental pulmonary embolism in a patient with cancer. Conclusion: A fixed dose of PCC appears to control hemostasis in patients with therapeutic plasma levels of apixaban or rivaroxaban requiring emergency surgery. Competing Interests: Declaration of competing interests S.S. served on data safety monitoring boards for Alexion, Bayer, Boehringer-Ingelheim, Regeneron, and Sanofi; served on a steering committee for Octapharma; served on event adjudication for Daiichi Sankyo and Takeda. V.B. received honorarium from Bayer. F.G.’s institution received research funding from Novo Nordisk, Roche, Takeda, Bayer, Pfizer, BioMarin, and CSL. R.I. received honoraria for advisory boards for Aspen, LeoPharma, Sanofi, and Inari. P.L.G. is named on a patent, “Novel methods to measure protease inhibitors.” N.C., A.I., S.M., and J.I.W. have no relevant conflicts. (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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