To evaluate the efficacy and safety of KW-3357 with concomitant use of heparin using multi-center, non-comparative, open-label method in patients diagnosed as disseminated intravascular coagulation (DIC) by Japanese Association for Acute Medicine-defined DIC criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Intravenous infusion once a day
Unnamed facility
Saga, Japan
Safety
Number of patients with adverse events
Time frame: up to 6 days (or discontinuation)
DIC resolution
Japanese Association for Acute Medicine-defined DIC criteria score \< 4
Time frame: 6 days (or discontinuation)
DIC score
Based on the Japanese Association for Acute Medicine-defined DIC criteria
Time frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Mortality
Time frame: 28 days
Organ symptoms
Sepsis related organ failure assessment score
Time frame: Screening, 4, 6 days (or discontinuation)
Severity
The Acute Physiology and Chronic Health Evaluation II score
Time frame: Screening, 4, 6 days (or discontinuation)
Plasma antithrombin activity
Time frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation)
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