The purpose of this study is to evaluate the efficacy and safety of KW-3357 compared to plasma-derived antithrombin using multi-center, open-label, parallel-group, comparative method in patients with Disseminated Intravascular Coagulation (DIC) associated with infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
221
Intravenous infusion once a day
Intravenous infusion once a day
Unnamed facility
Saga, Japan
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 score
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)
Number of patients with adverse events
Time frame: up to 6 days (or discontinuation)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.