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

Study Overview
=================
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

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

Conditions
-----------------
Heparin-induced Thrombocytopenia Type II

Intervention / Treatment
-----------------
* Drug: argatroban


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Argatroban<br> | Drug: argatroban<br> <br> |

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Argatroban, heparin induced thrombocytopenia (HIT), direct thrombin inhibitor (DTI)