Argatroban versus Lepirudin in critically ill patients (ALicia): a randomized controlled trial

INTRODUCTION: Critically 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. METHODS: Following 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. RESULTS: We 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. CONCLUSIONS: This 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 REGISTRATION: Clinical Trials.gov NCT00798525. Registered 25 November 2008.

Resumen tomado de PubMed (NCBI) para el registro citado, en el idioma original. La versión de referencia es la de la publicación original.

El resumen se deja sin traducir para conservar la redacción original de los autores.

First randomized double-blind trial comparing two direct thrombin inhibitors in 66 critically ill surgical patients with suspected HIT: argatroban and lepirudin showed comparable hemodialysis-filter lifetimes, but the trial suggests fewer bleeding events with argatroban than lepirudin (4 vs 11 patients, OR 3.9).

Explore cómo esta investigación se conecta con la práctica clínica

Más estudios revisados por pares en la categoría «Literatura clínica».

• Leech Therapy for Knee Osteoarthritis — The Landmark RCT — Michalsen et al. (2003)
• Leech-Assisted Flap Salvage — Systematic Review of 277 Cases — Whitaker et al. (2012)
• Efectos de la hirudoterapia sobre las funciones hepáticas, el perfil lipídico y la sensibilidad a la insulina en ratas con síndrome metabólico — Bilden A et al. (2026)
• Eficacia y seguridad de la hirudoterapia para mejorar los parámetros de calidad espermática en la infertilidad masculina: un ensayo controlado aleatorizado — Abtahi-Forooshani M et al. (2026)
• Congestión venosa de un colgajo sural reverso manejada con éxito con enoxaparina en un paciente varón con lesión traumática por aplastamiento del pie: un caso clínico — Velasco-Bustamante J et al. (2026)
• Investigación de los efectos terapéuticos del tratamiento con sanguijuelas medicinales sobre la lesión por isquemia-reperfusión de la extremidad inferior — Ünal K et al. (2026)
• Eficacia de la terapia con sanguijuelas medicinales en diversas aplicaciones clínicas: un estudio exhaustivo de Azerbaiyán — Farzali S et al. (2025)
• Hirudoterapia en cirugía reconstructiva: casos clínicos y revisión — Heinz P et al. (2020)
• Hirudoterapia en la cicatrización de heridas — Nair H et al. (2022)
• Hirudoterapia para la isquemia de las extremidades en la unidad de cuidados intensivos pediátricos: una cohorte observacional retrospectiva — Resch J et al. (2022)

Ver toda la investigación analizada por la ASH →