Disseminated intravascular coagulation (DIC) directly caused by malignant hematopoietic tumors or infections
Conditions
Interventions
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 ad
Sponsors
Asahi Kasei Pharma Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: (i)Patients showing lethal or life-threatening hemorrhage (intracranial, gastrointestinal or pulmonary hemorrhage, and others). (ii)Patients having a strong possibility of onset of lethal or life-threatening hemorrhage. (iii)Patients with a history (within the past one year) of cerebrovascular disorders (cerebral hemorrhage, cerebral infarction, and others). (iv)Patients who recently underwent surgery of the central nervous system or were subjected to trauma. (v)Children under 15. (vi)Patients with a history of hypersensitivity to protein preparations or unfractionated heparin preparations. (vii)Pregnant women, nursing mothers or possibly pregnant women. (viii)Patients whose skin test for ART-123 is positive. (ix)Patients undergoing treatment by dialysis or with drug excretion severely damaged by serious renal disorder. (x)Patients with serious hepatopathy such as fulminant hepatitis, uncompensated liver cirrhosis and others. (xi)Patients believed to die early even if they recovered from DIC, making it difficult to ensure a sufficient period of administration of the study drug and to obtain data on the efficacy and safety. (xii)Patients given a study drug within last 6 months. (xiii)Patients participating in the past trial of ART-123. (xiv)Patients receiving preadministration of unfractionated heparin for DIC (within 3 months before the start of administration of study drug). (xv)Other patients judged to be inappropriate at the discretion of investigators (or assistant investigators).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DIC restoration rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Outcome results
None listed