TerminatedPhase 2

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

Stopped: Experience gained from this study is sufficient to design and facilitate the follow-on study.

United States75 participantsStarted 2007-05-01

Plain-language summary

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.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 (…

What they're measuring

Cumulative Chest Tube Drainage During the First 12 Hours Postoperatively

Timeframe: Up to 12 hours post admission to intensive care unit (ICU)

Trial details

NCT IDNCT00448864

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-07-01

Results submitted2015-04-22