Argatroban versus Lepirudin in critically ill patients ALicia: a randomized controlled trialReport as inadecuate




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Critical Care

, 18:588

First Online: 25 October 2014Received: 13 May 2014Accepted: 13 October 2014

Abstract

IntroductionCritically ill patients often require renal replacement therapy accompanied by thrombocytopenia. Thrombocytopenia during heparin anticoagulation may be due to heparin-induced thrombocytopenia with need for alternative anticoagulation. Therefore, we compared argatroban and lepirudin in critically ill surgical patients.

MethodsFollowing institutional review board approval and written informed consent, critically ill surgical patients more than or equal to 18 years with suspected heparin-induced thrombocytopenia, were randomly assigned to receive double-blind argatroban or lepirudin anticoagulation targeting an activated Partial Thromboplastin Time aPTT of 1.5 to 2 times baseline. In patients requiring continuous renal replacement therapy we compared the life-time of hemodialysis filters. We evaluated in all patients the incidence of bleeding and thrombembolic events.

ResultsWe identified 66 patients with suspected heparin-induced thrombocytopenia, including 28 requiring renal replacement therapy. Mean filter lifetimes did not differ between groups argatroban 32 ± 25 hours n = 12 versus lepirudin 27 ± 21 hours n = 16, mean difference 5 hours, 95% CI −13 to 23, P = 0.227. Among all 66 patients, relevant bleeding occurred in four argatroban- versus eleven lepirudin-patients OR 3.9, 95% CI 1.1 to 14.0, P = 0.040. In the argatroban-group, three thromboembolic events occurred compared to two in the lepirudin group OR 0.7, 95% CI 0.1 to 4.4, P = 0.639. The incidence of confirmed heparin-induced thrombocytopenia was 23% n = 15 in our study population.

ConclusionsThis first randomized controlled double-blind trial comparing two direct thrombin inhibitors showed comparable effectiveness for renal replacement therapy, but suggests fewer bleeds in surgical patients with argatroban anticoagulation.

Trial registrationClinical Trials.gov NCT00798525. Registered 25 November 2008

AbbreviationsaPTTactivated partial thromboplastin time

CIconfidence interval

ELISAenzyme-linked immunosorbent assay

HIPAheparin-induced platelet activation assay

HITheparin-induced thrombocytopenia

ORodds ratio

Electronic supplementary materialThe online version of this article doi:10.1186-s13054-014-0588-8 contains supplementary material, which is available to authorized users.

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Author: Tanja A Treschan - Maximilian S Schaefer - Johann Geib - Astrid Bahlmann - Tobias Brezina - Patrick Werner - Elisabeth Go

Source: https://link.springer.com/







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