A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume
NCT ID: NCT00816023
Last Updated: 2015-08-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
276 participants
INTERVENTIONAL
2009-03-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Ecallantide Low Dose
target steady state concentration of 0.15 mg/L
ecallantide
infusion administered IV over the duration of the surgical procedure
Ecallantide Medium Dose
target steady state concentration of 0.75 mg/L
ecallantide
infusion administered IV over the duration of the surgical procedure
Ecallantide High Dose
target steady state concentration of 2.25 mg/L
ecallantide
infusion administered IV over the duration of the surgical procedure
Placebo
placebo
placebo
solution for IV infusion over the duration of the surgical\>\> procedure
Interventions
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ecallantide
infusion administered IV over the duration of the surgical procedure
placebo
solution for IV infusion over the duration of the surgical\>\> procedure
Eligibility Criteria
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Inclusion Criteria
* Planned primary CABG surgery including the use of cardio-pulmonary bypass.
Exclusion Criteria
* 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 \[\*Prophylactic use permitted for the prevention of deep vein thrombosis.\]
18 Years
85 Years
ALL
No
Sponsors
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Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Principal Investigators
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Alistair Wheeler, MD, MFPM
Role: STUDY_DIRECTOR
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Locations
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Cardio-Thoracic Surgeons PC
Birmingham, Alabama, United States
Drug Research and Analysis Corporation
Montgomery, Alabama, United States
University of Colorado - Denver
Aurora, Colorado, United States
Pepin Heart Hospital & Kiran Patel Research Institute
Tampa, Florida, United States
Indiana Ohio Heart
Fort Wayne, Indiana, United States
University of Kentucky
Lexington, Kentucky, 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
MCVI - Covenant Medical Center
Saginaw, Michigan, United States
MCVI - St. Mary's of Michigan
Saginaw, Michigan, United States
Mayo Clinic
Rochester, Minnesota, 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
Duke University Medical Center
Durham, North Carolina, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
East Tennessee Cardiovascular Surgery Group
Knoxville, Tennessee, United States
Texas Heart Institute
Houston, Texas, United States
Sentara Heart Hospital
Norfolk, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Charleston Area Medical Center (CAMC)
Charleston, West Virginia, United States
Foothills Medical Centre
Calgary, Alberta, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
New Brunswick Heart Centre
Saint John, New Brunswick, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Hospital Laval)
Québec, Quebec, Canada
Countries
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Other Identifiers
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ECAL-PCPB-08-02
Identifier Type: -
Identifier Source: org_study_id
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