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

Completed · Phase 2 · Has a placebo group

Conditions studied: Bloodloss, Surgical Procedures, Operative

In brief

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.

Key facts

Study ID

NCT00816023

Run by

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

276

Starts

2009-03-01

Expected to finish

2010-01-01

Last updated by the study team

2015-08-11

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.]

Where it is running

• 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

Full record on ClinicalTrials.gov

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