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