Overview

Argatroban Versus Lepirudin in Critically Ill Patients

Status:
Terminated
Trial end date:
2012-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to test the hypotheses that argatroban significantly increases efficacy and safety of renal replacement therapy measured as life time of haemodialysis filters as compared to lepirudin
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Treatments:
Antithrombins
Argatroban
Hirudins
Lepirudin
Criteria
Inclusion Criteria:

- Thrombocytopenia suspicious for HIT with decrease in platelet count >50% from baseline
obtained at hospital admission

- 4 T´s score for HIT probability >3 AND/OR positive ELISA for HIT

- Age ≥18 years

- Informed consent (if applicable)

Exclusion Criteria:

- 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

- Age<18 years

- Preexisting psychiatric/neurologic disorders with long-term inability to provide
informed consent