Critically ill patients are usually treated with heparin for anticoagulation. A serious complication of heparin therapy is heparin-induced thrombocytopenia type II (HIT). Patients with HIT have to receive alternative anticoagulants. We propose to test the hypotheses that argatroban significantly increases efficacy and safety of renal replacement therapy as measured by life time of hemodialysis filters when compared to lepirudin in critically ill patients. MedDRA version: 8.1 Level: LLT Classi
Conditions
Interventions
Trade Name: Argatra
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Refludan
Pharmaceutical Form: Powder for solution for infusion
Sponsors
Heinrich-Heine-Universität Düsseldorf
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult ICU patients (age =18 years) with thrombocytopenia suspicious for HIT with a decrease in platelet count by >50% from baseline and a 4 T´s score >3 (baseline defined as the highest value since start of heparin therapy)AND/OR positive inhouse HIT testing (ELISA). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Age 60 sec. - History of adverse events or sensitivity against study drugs - Pregnancy - Preexisting psychiatric/neurologic disorders with long-term inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Primary endpoint will be the mean runtime of two consecutive haemodialysis circuits from start till clotting. ;Main Objective: Main objective of the trial is to compare the efficacy of anticoagulation with argatroban or refludan in critically ill patients with HIT undergoing renal replacement therapy. The primary study endpoint is the mean running time of the two consecutive haemodialysis circuits in patients undergoing haemodialysis. ;Secondary Objective: Secondary objectives are controlability of dosing regimens, safety issues, such as incidence of bleeding, transfusion requirements, and incidence of thrombo-embolic events (thrombosis, stroke, gangrene, ischemia and limb amputation secondary to HIT), anaphylactic reactions, SUARS (Suspected unexpected serious adverse reactions), length of hospital stay, mortality during hospitalization and time till target aPTT. | — |
Countries
Germany
Outcome results
None listed