Phase III Clinical Study on ART-123 in patients with disseminated intravascular coagulation (DIC) directly caused by malignant hematopoietic tumors or infections (Multicenter double-blind randomized parallel group comparative study with heparin sodium as control drug)

INTERVENTION: ART‐123 (real drug or placebo) is administered at a dose of 0.06 mg/kg/day by intravenous drip for 30 min. This treatment is replaced once daily for 6 days. Heparin sodium (real drug or placebo) is administered at a daily dose of 8 units/kg/hr by intravenous drip for 24 hrs. This treatment is replaced for 6 days. CONDITION: Disseminated intravascular coagulation (DIC) directly caused by malignant hematopoietic tumors or infections PRIMARY OUTCOME: DIC restoration rate SECONDARY OUTCOME: Course of hemorrhage symptoms; Outcome of subjects; Rate of improvement of blood clotting test findings; Rate of improvement of organ symptoms; General improvement rate; Incidence rate of adverse events related to hemorrhage symptoms INCLUSION CRITERIA: (i)Patients given a diagnosis of DIC on the basis of criteria established by the DIC research group of the Ministry of Health and Welfare of Japan(1988 Revision). (ii)Patients with malignant hematopoietic tumors or infections as underlying diseases which directly caused DIC. ‐Details of malignant hematopoietic tumors: Acute myelocytic leukemia, acute lymphocytic leukemia, chronic myelocytic leukemia, chronic lymphocytic leukemia, adult T‐cell leukemia, malignant lymphoma, osteomyelodysplasia, multiple myeloma, and others. ‐Details of infections: Sepsis, pneumonia, urinary tract infection, biliary tract infection, viremia, peritonitis, abscess, burn/trauma/wound infections, and others. (iii)Inpatients (can be discharged after examinations/observations at the completion (or discontinuance) of administration of the study drug) (iv)Without distinction of sex