Clinical trial NCT00861692: Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II
Official title: An Open-label, Multi-centre, Clinical Study to Collect Information on the Clinical Use of Argatroban in Patients With Heparin Induced Thrombocytopenia (HIT) Type II Who Require Parenteral Antithrombotic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heparin-induced Thrombocytopenia Type II
Keywords: Argatroban
heparin induced thrombocytopenia (HIT)
direct thrombin inhibitor (DTI)
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2009-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to collect data on the clinical management of Argatroban in patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral antithrombotic therapy


Eligibility criteria: Inclusion Criteria:

* Subjects aged \>= 18 years
* Females of child bearing potential must have a negative urine pregnancy test prior to entry into the study
* Patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral anticoagulation
* Signed written informed consent by the subject, or if the subject is unable to do so, consent will be sought from their family member, or a trusted person nominated by the subject or the legal representative

Exclusion Criteria:

* Uncontrolled bleeding
* Severe hepatic impairment (Child-Pugh Class C)
* Hypersensitivity to argatroban or to any of the excipients (sorbitol and ethanol)
* Pregnancy (exclusion by routine urine test)
* Lactating woman

Primary outcomes:
measure: Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation
timeFrame: During and 30 days after argatroban treatment
measure: All-cause Death
timeFrame: During and 30 days after argatroban treatment
measure: Death Related to Heparin-induced Thrombocytopenia (HIT)
timeFrame: During and 30 days after argatroban treatment
measure: Number of Patients With Thrombosis (New and Extended)
timeFrame: During and 30 days after argatroban treatment
measure: Number of Patients With Unplanned Amputation
timeFrame: During and 30 days after argatroban treatment
measure: Number of Patients With Major or Minor Bleeding
timeFrame: During and 30 days after argatroban treatment
measure: Number of Patients With Platelet Count Recovery
timeFrame: Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Etienne
country: France
Study officials:
affiliation: Information at Mitsubishi Pharma Europe
name: Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tardy-Poncet B, Nguyen P, Thiranos JC, Morange PE, Biron-Andreani C, Gruel Y, Morel J, Wynckel A, Grunebaum L, Villacorta-Torres J, Grosjean S, de Maistre E. Argatroban in the management of heparin-induced thrombocytopenia: a multicenter clinical trial. Crit Care. 2015 Nov 11;19:396. doi: 10.1186/s13054-015-1109-0.