The purpose of the study is to evaluate efficacy and safety of argatroban in the patients with heparin-induced thrombocytopenia (HIT)/ HIT and thrombosis syndrome (HITTS). This multi-center trial covers mainly the patients with cardiovascular diseases. Subjects are included in the trial when they are clinically diagnosed of HIT/HITTS. Initial dose of argatroban is 0.7μg/kg/min, which is about one-third of the approved dose in the US. The reason of the lower initial dose is that the approved dose of argatroban in Japan (for the treatment of ischemic stroke) is about 0.7μg/kg/min and safety of higher doses of the drug are not confirmed. A sub-study of pharmacokinetics is simultaneously conducted to reveal the relationship among the dose, aPTT, and blood drug concentration.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
beginning dose: 0.7microgram/kg/H
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Nagoya Daini Red Cross Hospital
Nagoya, Aichi-ken, Japan
National Hospital Organization Hakodate National Hospital
Hakodate, Hokkaido, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Kurume University Hospital
Kurume, Hukuoka, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Kobe City General Hospital
Kobe, Hyōgo, Japan
Iwate Medical University Hospital
Morioka, Iwate, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
...and 10 more locations
Death, new thrombosis, amputation
Time frame: till 37 days
Achievement of anticoagulation therapy
Time frame: till 37 days
Improvement of thrombocytopenia
Time frame: till 37 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.