Andexanet Alfa for Acute Major Bleeding Associated with Factor Xa Inhibitors.

ABSTRACT:

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 millil

SUBMITTER: Connolly SJ 

PROVIDER: S-EPMC5568772 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature