Argatroban versus Lepirudin in Critically Ill Patients - ALiCia
- Conditions
- 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: 8.1Level: LLTClassification code 10062506Term: Heparin-induced thrombocytopenia
- Registration Number
- EUCTR2006-003122-28-DE
- Lead Sponsor
- Heinrich-Heine-Universität Düsseldorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
- Age < 18 years
- Transient thrombocytopenia due to intraoperative bleeding
- Active bleeding
- Intracranial operations
- Liver dysfunction with spontaneous aPTT> 60 sec.
- History of adverse events or sensitivity against study drugs
- Pregnancy
- Preexisting psychiatric/neurologic disorders with long-term inability to provide informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Primary endpoint will be the mean runtime of two consecutive haemodialysis circuits from start till clotting.<br>;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.<br><br> ;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.<br><br><br>
- Secondary Outcome Measures
Name Time Method