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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Re

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 Summary:
Sponsor: Mitsubishi Tanabe Pharma Corporation

Current Primary Outcome:

  • Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation [ Time Frame: During and 30 days after argatroban treatment ]
  • All-cause Death [ Time Frame: During and 30 days after argatroban treatment ]
  • Death Related to Heparin-induced Thrombocytopenia (HIT) [ Time Frame: During and 30 days after argatroban treatment ]
  • Number of Patients With Thrombosis (New and Extended) [ Time Frame: During and 30 days after argatroban treatment ]
  • Number of Patients With Unplanned Amputation [ Time Frame: During and 30 days after argatroban treatment ]
  • Number of Patients With Major or Minor Bleeding [ Time Frame: 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 [ Time Frame: Day 3 ]
    Platelet increase of ≥ 100G/L or 50%.


Original Primary Outcome:

  • Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation
  • All-cause Death
  • Death Related to HIT
  • Thrombosis (New and Extended)
  • Unplanned Amputation
  • Major / minor bleeding
  • PK/PD parameters


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mitsubishi Tanabe Pharma Corporation

Dates:
Date Received: March 12, 2009
Date Started: April 2009
Date Completion:
Last Updated: July 1, 2016
Last Verified: July 2016