Conditions: Disseminated Intravascular Coagulation
Keywords: DIC associated with severe sepsis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 25
Healthy volunteers: no

Brief summary:
The primary objective of the study is to explore the efficacy and safety of ATryn® (antithrombin alfa) for the treatment of disseminated intravascular coagulation (DIC) associated with severe sepsis, when administered by continuous intravenous (IV) infusion over five days.

Detailed description:

Arms:
arm 1: Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 125-175% arm 2: Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 225-275% arm 3: The best standard treatment for the underlying condition only

Interventions: intervention 1: Antithrombin alfa (INN name) intervention 2: Control (Standard treatment)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: