Conditions: Bloodloss Surgical Procedures, Operative
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 276
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the efficacy and identify the optimal dose(s) of ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery including the use of cardio pulmonary bypass.

Detailed description:

Arms:
arm 1: target steady state concentration of 0.15 mg/L arm 2: target steady state concentration of 0.75 mg/L arm 3: target steady state concentration of 2.25 mg/L arm 4: placebo

Interventions: intervention 1: ecallantide intervention 2: placebo
Intervention descriptions: intervention 1: infusion administered IV over the duration of the surgical procedure intervention 2: solution for IV infusion over the duration of the surgical\>\> procedure

Protocol document: