Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II

Phase 2

Completed

• Conditions: Heparin-induced Thrombocytopenia Type II
• Interventions: Drug: argatroban

• Registration Number: NCT00861692
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-12
• Study First Posted: 2009-03-13
• Study Start: 2009-04
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2015-11-17
• Results First Submitted QC: 2015-11-17
• Results First Posted: 2015-12-22
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-01
• Last Update Posted: 2016-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Argatroban	argatroban	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With Major or Minor Bleeding	During and 30 days after argatroban treatment	Major bleeding is defined as i) overt and associated with a fall in the haemoglobin level 2 g/dl or more, ii) leads to transfusion of 2 units or more, iii) is retroperitoneal, iv) occurs into a major prosthetic joint, or v) in intracranial.; Minor bleeding is defined as overt bleeding that does not meet the criteria of major bleeding.
Number of Patients With Platelet Count Recovery	Day 3	Platelet increase of ≥ 100G/L or 50%.
Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation	During and 30 days after argatroban treatment
All-cause Death	During and 30 days after argatroban treatment
Death Related to Heparin-induced Thrombocytopenia (HIT)	During and 30 days after argatroban treatment
Number of Patients With Thrombosis (New and Extended)	During and 30 days after argatroban treatment
Number of Patients With Unplanned Amputation	During and 30 days after argatroban treatment