Argatroban Versus Lepirudin in Critically Ill Patients

NCT00798525 | Terminated Phase 4 DMC

• 1 other identifier: 2006-003122-28
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Heparin Induced Thrombocytopenia (HIT)

Keywords

thrombocytopenia; Heparin; Lepirudin; Argatroban; critically ill patients

Outcome Measures

Primary Outcomes (1)

• Mean running time of a maximum of two consecutive haemodialysis circuits

  seven days starting at time of HIT suspicion

Secondary Outcomes (1)

• Incidence of bleeding, transfusion requirements, thromboembolic events, anaphylactic reactions, and SUSARs, length of hospital stay, mortality, time till target aPTT

  seven days starting at time of HIT suspicion

Study Arms (2)

PR1

ACTIVE COMPARATOR

Patients treated with Argatroban (Argatra®), a direct thrombin inhibitor

Drug: Argatroban

PR2

ACTIVE COMPARATOR

Patients treated with Lepirudin (Refludan®), a direct thrombin inhibitor

Drug: Lepirudin

Interventions

Argatroban DRUG

Argatra (Argatroban) will be diluted to 0.6 mg/ml and 0.5 µg/kg/min will be administered continuously in patients without liver disfunction. In patients with liver disfunction, defined by a bilirubin of \> 4mg/dl, argatroban will be administered as a continuous infusion of 0,25 µg/kg/min with a final concentration of 0,3 mg/ml.

Also known as: Argatra®, MA number: 62085.00.0

PR1

Lepirudin DRUG

Refludan (Lepirudin) will be diluted to a final concentration of 0.1mg/ml and initiated as a continuous infusion of 5µg/kg/h in patients with continuous renal replacement therapy. In patients with moderate renal impairment (Creatinine ≥1,3 mg/dl) a final concentration 0,2 mg/ml of will be used to provide continuous infusion of 10 µg/kg/h. Patients without renal impairment (Creatinine \< 1,3 mg/dl) will receive a continuous infusion of 50 µg/kg/h by a final concentration of 1 mg/ml of Lepirudin.

Also known as: Refludan®, MA number: EU/1/97/035/003

PR2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thrombocytopenia suspicious for HIT with decrease in platelet count \>50% from baseline obtained at hospital admission
• T´s score for HIT probability \>3 AND/OR positive ELISA for HIT
• Age ≥18 years
• Informed consent (if applicable)

You may not qualify if:

• 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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Universitätsklinikum Düsseldorf Klinik für Anästhesiologie

Düsseldorf, 40225, Germany

Location

Related Publications (3)

• Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.

  PMID: 33314078 DERIVED

• Beiderlinden M, Werner P, Bahlmann A, Kemper J, Brezina T, Schafer M, Gorlinger K, Seidel H, Kienbaum P, Treschan TA. Monitoring of argatroban and lepirudin anticoagulation in critically ill patients by conventional laboratory parameters and rotational thromboelastometry - a prospectively controlled randomized double-blind clinical trial. BMC Anesthesiol. 2018 Feb 9;18(1):18. doi: 10.1186/s12871-018-0475-y.

  PMID: 29426286 DERIVED

• Treschan TA, Schaefer MS, Geib J, Bahlmann A, Brezina T, Werner P, Golla E, Greinacher A, Pannen B, Kindgen-Milles D, Kienbaum P, Beiderlinden M. Argatroban versus Lepirudin in critically ill patients (ALicia): a randomized controlled trial. Crit Care. 2014 Oct 25;18(5):588. doi: 10.1186/s13054-014-0588-8.

  PMID: 25344113 DERIVED

MeSH Terms

Conditions

Thrombocytopenia

Interventions

argatroban; lepirudin

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Peter Kienbaum, MD

  Uniklinik Düsseldorf, Klinik für Anästhesiologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 26, 2008
• Study Start: January 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 21, 2012

Record last verified: 2012-06

Locations

DE (1)