A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume

Inclusion Criteria:

- Written informed consent (by study subject or appropriate legal representative) prior
to any study-related procedure not part of normal medical care

- Planned primary CABG surgery including the use of cardio-pulmonary bypass.

Exclusion Criteria:

- Planned concomitant surgery including ASD repair, valve replacement, carotid
endarterectomy, CABG combined procedures or any repeat sternotomy;

- Body weight <55 kg;

- Planned hypothermia (<28ºC);

- Planned transfusion in the peri-operative or post-operative periods;

- Planned transfusion of pre-operatively donated autologous blood;

- Female subjects who are pregnant or lactating;

- Planned use of desmopressin, lysine analogs, atrial natriuretic hormone or
recombinant activated Factor VII;

- Planned use of corticosteroids in the pump prime solution;

- Ejection fraction <30% within 90 days prior to surgery;

- Evidence of a myocardial infarction within 5 days prior to surgery;

- History of stroke or transient ischemic attack within 3 months prior to surgery;

- Hypotension or heart failure requiring the use of inotropes or mechanical devices
within 24 hours prior to surgery;

- Serum creatinine >2.0 mg/dL within 48 hours prior to surgery;

- Serum hepatic enzymes above 2.5 times the upper limit of normal for the applicable
laboratory;

- Hematocrit <32% within 48 hours prior to surgery;

- Platelet count below the normal range for the applicable laboratory within 14 days
prior to surgery;

- History of, or family history of, bleeding or clotting disorder or thrombophilia;

- History of heparin-induced thrombocytopenia;

- Prothrombin time and/or activated partial thromboplastin time >1.5 X normal range;

- Serious intercurrent illness or active infection;

- Any previous exposure to ecallantide;

- Receipt of an investigational drug or device 30 days prior to participation in the
current study;

- Known allergy to any agent expected to be used in the intra-operative or
post-operative periods; and

- Administration of: Eptifibatide within 6 hours prior to surgery, Tirofiban HCl within
6 hours prior to surgery, *Enoxaparin sodium or other low-molecular-weight heparin
<24 hours prior to surgery, Clopidogrel within 5 days prior to surgery, Ticlopidine
within 7 days prior to surgery, Abciximab within 5 days prior to surgery,
*Bivalirudin, argatroban or lepirudin within 6 hours prior to surgery, *Fondaparinux
within 72 hours prior to surgery, Prasugrel within 10 days prior to surgery
[*Prophylactic use permitted for the prevention of deep vein thrombosis.]