A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume
Condition: Bloodloss; Surgical Procedures, Operative
MeSH terms: Blood Loss, Surgical
Intervention: ecallantide; placebo
Intervention description: infusion administered IV over the duration of the surgical procedure; solution for IV infusion over the duration of the surgical>> procedure
Intervention MeSH terms: Ecallantide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 276.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.]