Disseminated Intravascular Coagulation (DIC)
Conditions
Brief summary
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.
Interventions
DRUGKW-3357
Intravenous infusion once a day
DRUGPlasma-derived antithrombin
Intravenous infusion once a day
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meet the ACCP/SCCM-defined sepsis criteria * Japanese Association for Acute Medicine-defined DIC criteria score \>= 4 * Antithrombin activity \<= 70% * Written informed consent from patient or guardian
Exclusion criteria
* Anamnesis or complication of serious drug allergy * Serious liver disorder, such as fulminant hepatitis and decompensated cirrhosis * Pregnant, nursing, or possibly pregnant woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DIC resolution | 6 days (or discontinuation) | Japanese Association for Acute Medicine-defined DIC criteria score \< 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Organ symptoms | Screening, 4, 6 days (or discontinuation) | Sepsis related organ failure assessment score |
| DIC score | Screening, 2, 3, 4, 5, 6 days (or discontinuation) | Based on the Japanese Association for Acute Medicine-defined DIC criteria score |
| Severity | Screening, 4, 6 days (or discontinuation) | The Acute Physiology and Chronic Health Evaluation II score |
| Plasma antithrombin activity | Screening, 2, 3, 4, 5, 6 days (or discontinuation) | — |
| Number of patients with adverse events | up to 6 days (or discontinuation) | — |
| Mortality | 28 days | — |
Countries
Japan
Outcome results
None listed