作者
Stuart J Connolly, Truman J Milling Jr, John W Eikelboom, C Michael Gibson, John T Curnutte, Alex Gold, Michele D Bronson, Genmin Lu, Pamela B Conley, Peter Verhamme, Jeannot Schmidt, Saskia Middeldorp, Alexander T Cohen, Jan Beyer-Westendorf, Pierre Albaladejo, Jose Lopez-Sendon, Shelly Goodman, Janet Leeds, Brian L Wiens, Deborah M Siegal, Elena Zotova, Brandi Meeks, Juliet Nakamya, W Ting Lim, Mark Crowther
发表日期
2016/9/22
期刊
New England Journal of Medicine
卷号
375
期号
12
页码范围
1131-1141
出版商
Massachusetts Medical Society
简介
Background
Andexanet alfa (andexanet) is a recombinant modified human factor Xa decoy protein that has been shown to reverse the inhibition of factor Xa in healthy volunteers.
Methods
In this multicenter, prospective, open-label, single-group study, we evaluated 67 patients who had acute major bleeding within 18 hours after the administration of a factor Xa inhibitor. The patients all received a bolus of andexanet followed by a 2-hour infusion of the drug. Patients were evaluated for changes in measures of anti–factor Xa activity and were assessed for clinical hemostatic efficacy during a 12-hour period. All the patients were subsequently followed for 30 days. The efficacy population of 47 patients had a baseline value for anti–factor Xa activity of at least 75 ng per milliliter (or ≥0.5 IU per milliliter for those receiving enoxaparin) and had confirmed bleeding severity at adjudication.
Results
The mean age of the …
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SJ Connolly, TJ Milling Jr, JW Eikelboom, CM Gibson… - New England Journal of Medicine, 2016