Letter

Increased bleeding risk associated with the use of recombinant human activated protein C in patients with advanced liver disease

Adam Keene1*, Thomas Kawano2, Syed Anees3 and Julie Chen4

Author Affiliations

1 Division of Critical Care Medicine, Montefiore Medical Center, Bronx, New York, USA

2 Department of Internal Medicine, Montefiore Medical Center, Bronx, New York, USA

3 Division of Pulmonary Medicine, Montefiore Medical Center, Bronx, New York, USA

4 Division of Pharmacy, Montefiore Medical Center, Bronx, New York, USA

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Critical Care 2008, 12:405 doi:10.1186/cc6774

Published: 11 February 2008

First paragraph (this article has no abstract)

Advanced liver disease (ALD) was an exclusion criteria from enrollment in the major clinical trials of recombinant human activated protein C (APC), but is listed on the package insert as a relative contraindication rather than an absolute contra-indication to APC administration [1]. There are recent reports of elevated rates of bleeding due to APC in clinical practice, particularly in patients with relative contraindications to the drug [2,3]. Since many patients who develop septic shock at Montefiore Medical Center in the Bronx, New York have ALD, we decided to evaluate whether such patients have an increased risk for bleeding during APC administration.