Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Blood Loss, Surgical

In brief

The primary objective of this study was to assess the efficacy and safety of 2 dose levels of ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as measured by chest tube drainage during the first 12 hours postoperatively or until the chest tube was removed, whichever came first, in patients undergoing primary coronary artery bypass grafting (CABG), single valve repair, or single valve replacement. The secondary objective was to compare the efficacy of all ecallantide-treated participants (pooled high and low-doses) to placebo and to compare the high-dose to the low-dose ecallantide group. Other secondary objectives were to evaluate pharmacokinetics and antibody formation.

Key facts

Study ID

NCT00448864

Run by

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

People needed

75

Starts

2007-05-01

Expected to finish

2008-08-01

Last updated by the study team

2019-06-25

Who can join

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

You may qualify if…

• Men and women ≥18 to ≤85 years of age
• Elective primary coronary artery bypass grafting (CABG), single valve repair, or single valve replacement requiring CPB and full sternotomy
• No plan to use desmopressin acetate (DDAVP), atrial natriuretic hormone, E-aminocaproic acid (EACA), tranexamic acid, or aprotinin during or postoperatively
• Female participants must be non-lactating and not pregnant
• If of childbearing potential, female participants must agree to use adequate contraception for 1 month after receiving study drug

You may not qualify if…

• Concomitant surgery including but not limited to atrial septal defect repair, multiple valve replacement, carotid endarterectomy, and combined CABG and valve procedure
• Planned hypothermic CPB using temperatures less than 28 degrees Celsius
• Weight <55 kilograms (kg)
• Major end organ dysfunction, defined as:
• Cardiac:
• Left ventricular ejection fraction (LVEF) < 30% by left ventriculography, echocardiogram, or catheterization (within 90 days prior to screening)
• Use of positive IV inotropic agents within 12 hours prior to surgery
• Preoperative use of intra-aortic balloon pump (IABP), left ventricular assist device (LVAD), or extracorporeal membrane oxygenation (ECMO)
• Renal: Serum creatinine > 1.5 milligrams per deciliter (mg/dL)
• Hepatic: Aspartate aminotransferase (AST) or alanine transferase (ALT) > 2.5 x upper limit normal
• Hematologic:
• Preoperative hematocrit (Hct) < 30%
• Platelet count < 100,000/mm\^3
• Planned transfusion during surgical procedure
• History or family history of bleeding or clotting disorder (for example, von Willebrand's Disease, idiopathic thrombocytopenia purpura (ITP), thrombotic thrombocytopenia purpura (TTP), hematologic malignancy)
• Prothrombin time (PT) or activated partial thromboplastin time
• (aPTT) > 1.5 x normal range; if receiving unfractionated heparin preoperatively, then abnormal preoperative PT/aPTT permitted
• Serious intercurrent illness or active infection
• Previous exposure to ecallantide
• Known allergy to ecallantide or any of its components, fentanyl, midazolam, isoflurane, propofol, morphine, heparin, or protamine
• Autologous blood donation ≤ 30 days month prior to surgery
• Known substance abuse within 6 months prior to surgery
• Receipt of an investigational drug or device within 30 days prior to participation in the current study
• Administration of:
• Eptifibatide < 12 hours prior to surgery

Where it is running

• St. Vincent's Hospital — Birmingham, Alabama, United States
• Mayo Clinic Hospital — Phoenix, Arizona, United States
• University of Colorado — Aurora, Colorado, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's 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
• SUNY Upstate Medical University — Syracuse, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Gaston Memorial Hospital — Gastonia, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• The Methodist Hospital — Houston, Texas, United States
• Texas Heart Institute — Houston, Texas, United States

Full record on ClinicalTrials.gov

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