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

This study has been terminated.
(Experience gained from this study is sufficient to design and facilitate the follow-on study)
Sponsor:
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00448864
First received: March 16, 2007
Last updated: September 9, 2008
Last verified: September 2008
  Purpose

The purpose of this study is to evaluate two different dose regimens of ecallantide to determine whether either or both dose regimens reduce blood loss, measured by chest tube drainage, compared to placebo during cardiopulmonary bypass surgery.


Condition Intervention Phase
Blood Loss, Surgical
Drug: ecallantide
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: DX-88 (Ecallantide) for the Reduction of Blood Loss Associated With Cardiopulmonary Bypass: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study in Patients Undergoing Primary Coronary Artery Bypass Grafting, Single Valve Repair or Single Valve Replacement

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:
  • Chest tube drainage during the first 12 hours postoperatively [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cumulative chest tube drainage at 24 hours postoperatively or until chest tube removal [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Safety and tolerability of DX-88 (ecallantide) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of DX-88 (ecallantide) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: April 2007
Study Completion Date: August 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
DX-88 (ecallantide) - low dose regimen
Drug: ecallantide
solution for IV infusion over the duration of the surgical procedure
Other Name: DX-88
Experimental: 2
DX-88 (ecallantide) - high dose regimen
Drug: ecallantide
solution for IV infusion over the duration of the surgical procedure
Other Name: DX-88
Placebo Comparator: 3
Placebo
Drug: placebo
solution for IV infusion over the duration of the surgical procedure

Detailed Description:

This is a placebo-controlled trial. Patients are randomized to intravenous administration of high dose ecallantide, low dose ecallantide, or placebo.

The study is designed to evaluate the potential for transfusion reduction in patients receiving ecallantide undergoing cardiopulmonary bypass during primary coronary bypass graft, isolated valve repair, or isolated valve replacement surgery by measuring thoracic drainage. This study is designed to provide data determining the effect of kallikrein inhibition or kallikrein plus plasmin inhibition, compared to placebo, in reducing chest tube drainage. These data are anticipated to support the dose selection in subsequent larger studies to demonstrate the safety and efficacy of ecallantide. Efficacy, safety and pharmacokinetics of ecallantide will be evaluated in this study.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women age 18 to 79
  • Elective primary CABG, single valve repair, or single valve replacement requiring CPB and sternotomy
  • No plan to use desmopressin acetate (DDAVP), atrial natriuretic hormone, EACA, tranexamic acid or aprotinin during or postoperatively
  • Female patients must be non-lactating and not pregnant
  • If of childbearing potential, female patients must agree to use adequate contraception for 1 month after receiving study drug

Exclusion Criteria:

  • Concomitant surgery
  • Planned hypothermic CPB using temperatures less than 28C
  • Weight < 55 kg
  • Major end organ dysfunction
  • Serious intercurrent illness or active infection
  • Previous exposure to DX-88 (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
  • Receipt of an investigational drug or device within 30 days prior to surgery
  • Administration prior to surgery of Eptifibatide, Tirofiban HCl, enoxaparin sodium or other low molecular weight heparin, Clopidogrel, Warfarin, Ticlopidine, Abciximab
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448864

Locations
United States, Alabama
St. Vincent's Hospital
Birmingham, Alabama, United States, 35205
United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Gaston Memorial Hospital
Gastonia, North Carolina, United States, 28054
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Texas Heart Institute
Houston, Texas, United States, 77225
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cubist Pharmaceuticals
Investigators
Study Director: Andrew L Sternlicht, MD Dyax Corp.
  More Information

No publications provided

Responsible Party: Ed Campanaro, Cubist Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00448864     History of Changes
Other Study ID Numbers: DX-88/16
Study First Received: March 16, 2007
Last Updated: September 9, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications

ClinicalTrials.gov processed this record on August 27, 2014