A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume
- Conditions
- BloodlossSurgical Procedures, Operative
- Interventions
- Drug: placebo
- Registration Number
- NCT00816023
- Lead Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 276
- 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.
- 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.]
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo placebo Ecallantide Medium Dose ecallantide target steady state concentration of 0.75 mg/L Ecallantide Low Dose ecallantide target steady state concentration of 0.15 mg/L Ecallantide High Dose ecallantide target steady state concentration of 2.25 mg/L
- Primary Outcome Measures
Name Time Method Cumulative Volume of Packed Red Blood Cells Transfused at 12 Hours Post Surgery Start of surgery up to 12 hours after the end of surgery
- Secondary Outcome Measures
Name Time Method Treatment-emergent Adverse Events Over the duration of the study.
Trial Locations
- Locations (29)
Drug Research and Analysis Corporation
🇺🇸Montgomery, Alabama, United States
Pepin Heart Hospital & Kiran Patel Research Institute
🇺🇸Tampa, Florida, United States
Indiana Ohio Heart
🇺🇸Fort Wayne, Indiana, United States
MCVI - Covenant Medical Center
🇺🇸Saginaw, Michigan, United States
MCVI - St. Mary's of Michigan
🇺🇸Saginaw, Michigan, United States
St. Luke's - Roosevelt Hospital Center
🇺🇸New York, New York, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Sentara Heart Hospital
🇺🇸Norfolk, Virginia, United States
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
New Brunswick Heart Centre
🇨🇦Saint John, New Brunswick, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Hospital Laval)
🇨🇦Quebec, Canada
East Tennessee Cardiovascular Surgery Group
🇺🇸Knoxville, Tennessee, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Charleston Area Medical Center (CAMC)
🇺🇸Charleston, West Virginia, United States
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
University of Colorado - Denver
🇺🇸Aurora, Colorado, United States
Cardio-Thoracic Surgeons PC
🇺🇸Birmingham, Alabama, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Caritas St. Elizabeth's Medical Center
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Texas Heart Institute
🇺🇸Houston, Texas, United States
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
University of Kentucky
🇺🇸Lexington, Kentucky, United States