Heparin-Induced Thrombocytopenia
Conditions
Interventions
Intervention type:DRUG
Name of intervention:Argatroban
Dose form / Japanese Medical Device Nomenclature:
Route of administration / Site of application:
Dose per administration:
Dosing frequency / Freq
Sponsors
National Cardiovascular Center
Iwate Medical University Hospital, Kyoto University Hospital, Kyoto Second Red cross Hospital, Kurume University Hospital, Keio University Hospital, Kobe City General Hospital, Kobe University Hospital, Sakakibara Memorial Hospital, Tokai University Hospital, The University of Tokyo Hospital, National Hospital Organization Iwakuni Clinical Center, National Hospital Organization Tokyo Medical Center, National Hospital Organization Nagoya Medical Center, National Hospital Organization Hakodate Nat
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1.Those with the diagnosis of HIT or HITTS made by the following diagnostic criteria, or those who have positive results of HIT antibody 1)diagnostic criteria of HIT a fall in platelet count to less than 100,000/mcL or a 50% decrease in platelets after the initiation of heparin therapy with no apparent explanation other than HIT 2)diagnostic criteria of HITTS i) those who met the diagnosis criteria of HIT ii) presence of an arterial or venous thrombosis documented by appropriate imaging technique (ultrasound, angiography etc.) or supported by clinical evidence such as a myocardial infarction, stroke, pulmonary embolism, or other clinical indications of vascular occlusion(absence of pulse, cold, cyanotic extremities, etc.) 3)patients with history of HIT/HITTS with positive test results (HIT antibody or platelet function test) could be enrolled without present thrombocytopenia 2.Patients willing and able to give informed consent
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1.any condition which in the investigator's opinion, contraindicated the use of argatroban or endangered the patient if he or she participated in this trial 2.clinically significant or uncontrolled endocrine, renal, pulmonary, gastrointestinal, or psychiatric disorder of sufficient severity that the investigator deemd antithrombotic therapy with argatroban to be contraindicated 3.unexplained aPTT>200% of control at baseline 4.documented coagulation disorder or unexplained bleeding diathesis unrelated to HIT 5.lunbar puncture within the past 7 days 6.known clinical site of bleeding. Patients with a known site of clinical bleeding could be enrolled if the investigator deemed the risk of continued thrombosis outweighed the potential bleeding risk 7.serious liver disfunction 8.females of known or suspected pregnancy 9.breast feeding females 10.participation in other clinical drug trials within the past 30 days 11.history of hypersensitivity to argatroban 12.concomitant use of cimetidine 13.previous participation in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of thrombosis, amputation and death | — |
Secondary
| Measure | Time frame |
|---|---|
| the incidence of all death; the incidence of new thrombosis; the incidence of amputation; the incidence of death from thrombosis; acievement of anticoagulation therapy; improvement of thrombocytopenia | — |
Countries
Japan
Outcome results
None listed