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

Primary Purpose

Coronary Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
INS50589 Intravenous Infusion
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Disease focused on measuring Coronary Artery Bypass Graft Surgery involving Cardiopulmonary Bypass

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Baptist Medical Center Princeton
  • Cardiology, P.C.
  • Sharp Memorial Hospital
  • Memorial Medical Center
  • St. John's Hospital
  • Southern Illinois University School of Medicine
  • Lutheran Hospital of Indiana
  • Veterans Affairs Medical Center
  • University of Kentucky, Chandler Medical Center
  • St. Mary's of Michigan
  • Covenant Medical Center
  • Viahealth Rochester General Hospital
  • Duke University Medical Center
  • The Brody School of Medicine, East Carolina University
  • Cardiac, Vascular, & Thoracic Surgeons, Inc.
  • Good Samaritan Hospital
  • Bethesda North Hospital
  • Oklahoma Cardiovascular Associates
  • Oklahoma Cardiovascular Research Group
  • Oklahoma Heart Hospital
  • CardioThoracic Surgery Center, PLC
  • Jackson Madison County General Hospital
  • Centennial Medical Center
  • The Methodist Hospital
  • Winchester Medical Center
  • FHS Research Center, St. Joseph Medical Center
  • Northwest Cardiovascular Associates

Outcomes

Primary Outcome Measures

Postoperative chest drainage volume

Secondary Outcome Measures

Requirement for perioperative blood product transfusion
Incidence of complications after surgery

Full Information

First Posted
April 18, 2006
Last Updated
November 17, 2016
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00316212
Brief Title
Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Grafting (CABG) Involving Cardiopulmonary Bypass
Official Title
Randomized, Multicenter, Placebo-Controlled, Double-Blind, Parallel Group Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Graft Surgery Involving Cardiopulmonary Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Study Start Date
April 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Coronary Artery Bypass Graft Surgery involving Cardiopulmonary Bypass

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
INS50589 Intravenous Infusion
Primary Outcome Measure Information:
Title
Postoperative chest drainage volume
Secondary Outcome Measure Information:
Title
Requirement for perioperative blood product transfusion
Title
Incidence of complications after surgery

10. Eligibility

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

12. IPD Sharing Statement

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

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