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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KW-3357 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KW-3357 | Drug | Intravenous infusion once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Number of patients with adverse events | up to 6 days (or discontinuation) |
| DIC resolution | Japanese Association for Acute Medicine-defined DIC criteria score < 4 | 6 days (or discontinuation) |
| DIC score | Based on the Japanese Association for Acute Medicine-defined DIC criteria | Screening, 2, 3, 4, 5, 6 days (or discontinuation) |
| Mortality | 28 days | |
| Organ symptoms | Sepsis related organ failure assessment score | Screening, 4, 6 days (or discontinuation) |
| Severity | The Acute Physiology and Chronic Health Evaluation II score | Screening, 4, 6 days (or discontinuation) |
| Plasma antithrombin activity | Screening, 2, 3, 4, 5, 6 days (or discontinuation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saga | Japan |
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| ID | Term |
|---|---|
| D004211 | Disseminated Intravascular Coagulation |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
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| D019851 | Thrombophilia |