Conditions: Bloodloss Surgical Procedures, Operative
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 243
Healthy volunteers: no

Brief summary:
A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Ecallantide intervention 2: Cyklokapron(R)
Intervention descriptions: intervention 1: 2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion intervention 2: 1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime

Protocol document: