Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Grafting (CABG) Involving Cardiopulmonary Bypass

November 17, 2016 updated by: Merck Sharp & Dohme LLC

Randomized, Multicenter, Placebo-Controlled, Double-Blind, Parallel Group Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Graft Surgery Involving Cardiopulmonary Bypass

The purpose of this trial is to identify a dose or doses of INS50589 intravenous infusion that are well-tolerated and which reduce postoperative bleeding and blood product transfusion.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Baptist Medical Center Princeton
      • Birmingham, Alabama, United States, 35211
        • Cardiology, P.C.
    • California
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Memorial Medical Center
      • Springfield, Illinois, United States, 62769
        • St. John's Hospital
      • Springfield, Illinois, United States, 62794-9638
        • Southern Illinois University School of Medicine
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Lutheran Hospital of Indiana
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Veterans Affairs Medical Center
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky, Chandler Medical Center
    • Michigan
      • Saginaw, Michigan, United States, 48602
        • Covenant Medical Center
      • Saginaw, Michigan, United States, 48601
        • St. Mary's of Michigan
    • New York
      • Rochester, New York, United States, 14621
        • Viahealth Rochester General Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Greenville, North Carolina, United States, 27834
        • The Brody School of Medicine, East Carolina University
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital
      • Cincinnati, Ohio, United States, 45209
        • Cardiac, Vascular, & Thoracic Surgeons, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Heart Hospital
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Cardiovascular Research Group
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Cardiovascular Associates
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • Jackson Madison County General Hospital
      • Jackson, Tennessee, United States, 38301
        • CardioThoracic Surgery Center, PLC
      • Nashville, Tennessee, United States, 37203
        • Centennial Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
    • Virginia
      • Winchester, Virginia, United States, 22601
        • Winchester Medical Center
    • Washington
      • Tacoma, Washington, United States, 98405
        • FHS Research Center, St. Joseph Medical Center
      • Tacoma, Washington, United States, 98405
        • Northwest Cardiovascular Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Are scheduled for primary CABG by median sternotomy involving cardiopulmonary bypass
  • Willing to receive allogeneic blood product transfusions during and after surgery

Exclusion Criteria:

  • Have had previous cardiac surgery
  • Have had previous median sternotomy
  • Have tendency for bleeding or family history of bleeding
  • Have an abnormally low platelet count
  • Have received certain anticoagulant or antiplatelet medications within a specified time period prior to the scheduled CABG surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Postoperative chest drainage volume

Secondary Outcome Measures

Outcome Measure
Requirement for perioperative blood product transfusion
Incidence of complications after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

April 18, 2006

First Submitted That Met QC Criteria

April 18, 2006

First Posted (Estimate)

April 20, 2006

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 17, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 025-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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