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

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

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

Study Overview

• Status: Completed
• Conditions: Heparin-induced Thrombocytopenia Type II
• Intervention / Treatment: Drug: argatroban

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Saint-Etienne, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Argatroban	Drug: argatroban

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of Patients With Major or Minor Bleeding	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.	During and 30 days after argatroban treatment
Number of Patients With Platelet Count Recovery	Platelet increase of ≥ 100G/L or 50%.	Day 3

Collaborators and Investigators

• Sponsor: Tanabe Pharma Corporation
• Investigators: Principal Investigator: Professor, Information at Mitsubishi Pharma Europe

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: March 12, 2009
• First Submitted That Met QC Criteria: March 12, 2009
• First Posted (Estimated): March 13, 2009

Study Record Updates

• Last Update Posted (Estimated): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Argatroban; heparin induced thrombocytopenia (HIT); direct thrombin inhibitor (DTI)
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; argatroban
• Other Study ID Numbers: ARG-E07