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Status:

TERMINATED

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

Lead Sponsor:

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

Conditions:

Blood Loss, Surgical

Eligibility:

All Genders

18-85 years

Phase:

PHASE2

Brief 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 c...

Detailed Description

This was a Phase 2, randomized, double-blind, placebo-controlled, multi-center study designed to assess the efficacy and safety of 2 dose levels of ecallantide compared to placebo in reducing chest tu...

Eligibility Criteria

Inclusion

  • 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

  • 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
  • Tirofiban hydrochloride (HCl) \< 12 hours prior to surgery
  • Enoxaparin sodium or other low- molecular-weight heparin \< 24 hours prior to surgery
  • Clopidogrel \<5 days prior to surgery
  • Warfarin \<5 days prior to surgery (Warfarin must be discontinued 5 days prior to surgery and PT must be \< 18 seconds)
  • Ticlopidine \<7 days prior to surgery
  • Abciximab \<24 hours prior to surgery

Key Trial Info

Start Date :

May 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2008

Estimated Enrollment :

75 Patients enrolled

Trial Details

Trial ID

NCT00448864

Start Date

May 1 2007

End Date

August 1 2008

Last Update

June 25 2019

Active Locations (15)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (15 locations)

1

St. Vincent's Hospital

Birmingham, Alabama, United States, 35205

2

Mayo Clinic Hospital

Phoenix, Arizona, United States, 85054

3

University of Colorado

Aurora, Colorado, United States, 80045

4

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114