Disseminated Intravascular Coagulation, Sepsis
Conditions
Brief summary
The purpose of this study is to see if ART-123 (recombinant human soluble thrombomodulin) decreases the number of people who die as a result of Disseminated Intravascular Coagulation (DIC) complication of sepsis.
Interventions
DRUGART-123
6mg/ml ampule solution for injection @ .01mg/kg
DRUGplacebo
6 mg/ml ampule solution for injection at .01mg/kg
Sponsors
Artisan Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Infection or suspected infection resulting in sepsis and DIC
Exclusion criteria
* Unable to provide informed consent, or lack of consent from an acceptable surrogate * Subjects \< 18 years of age * Known conditions that could confound the diagnosis of DIC due to sepsis * Known conditions that increase the risk of bleeding * Known medical condition associated with a hypercoagulable state * Known or suspected severe liver disease * History of solid organ (excluding uncomplicated kidney), bone marrow or stem cell transplantation * Renal failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-Day All-cause mortality | 28 day |
Countries
Canada, Malaysia, Thailand, United States
Outcome results
None listed