Bleeding risk factors associated with argatroban therapy in the critically ill.

Argatroban is a parenteral direct thrombin inhibitor labeled for anticoagulation in patients with confirmed or suspected heparin-induced thrombocytopenia in the United States. Currently there are no studies evaluating bleeding risk factors in Intensive Care Unit patients.To determine bleeding risk factors associated with argatroban therapy in the critically ill. Critically ill patients admitted between July 2007-June 2008 who received argatroban were included in this retrospective cohort study. The primary endpoint was the incidence of bleeding complications associated with argatroban. Major bleeding was defined as a hemoglobin reduction ≥2 g/dL plus a transfusion of ≥2 units of blood in a 24 h period, or a retroperitoneal, intracranial, prosthetic joint, or other life-threatening bleed. Minor bleeding was any overt bleeding not fitting the major bleeding definition. Secondary outcomes included identifying risk factors for bleeding. Seventy-three patients were included with 16 (21.9%) total bleeding complications, 7 (9.6%) major and 9 (12.3%) minor bleeds. Four risk factors for bleeding were identified by univariate analysis: major surgery prior to or during argatroban therapy (OR = 8.4, 95% CI: 2.3-30.1, p = 0.001), dosing weight >90 kg (OR = 4.8, 95% CI: 1.4-15.8, p = 0.01), total bilirubin >3 mg/dL (OR = 8.1, 95% CI: 2.1-31.1, p = 0.002), and baseline platelets ≤70 K/μL (OR = 4.2, 95 % CI: 1.1-16.3, p = 0.039).Risks and benefits of argatroban should be weighed in patients with major surgery prior to or during argatroban, dosing weight ≥90 kg, total bilirubin ≥3 mg/dL, and baseline platelets ≤70 K/μL.