Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Grafting (CABG) Involving Cardiopulmonary Bypass
Randomized, Multicenter, Placebo-Controlled, Double-Blind, Parallel Group Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Graft Surgery Involving Cardiopulmonary Bypass
1 other identifier
interventional
160
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 18, 2006
CompletedFirst Posted
Study publicly available on registry
April 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedNovember 18, 2016
November 1, 2016
4 months
April 18, 2006
November 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative chest drainage volume
Secondary Outcomes (2)
Requirement for perioperative blood product transfusion
Incidence of complications after surgery
Interventions
Eligibility Criteria
You may qualify if:
- Are scheduled for primary CABG by median sternotomy involving cardiopulmonary bypass
- Willing to receive allogeneic blood product transfusions during and after surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Baptist Medical Center Princeton
Birmingham, Alabama, 35211, United States
Cardiology, P.C.
Birmingham, Alabama, 35211, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
Memorial Medical Center
Springfield, Illinois, 62702, United States
St. John's Hospital
Springfield, Illinois, 62769, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62794-9638, United States
Lutheran Hospital of Indiana
Fort Wayne, Indiana, 46804, United States
Veterans Affairs Medical Center
Lexington, Kentucky, 40506, United States
University of Kentucky, Chandler Medical Center
Lexington, Kentucky, 40536, United States
St. Mary's of Michigan
Saginaw, Michigan, 48601, United States
Covenant Medical Center
Saginaw, Michigan, 48602, United States
Viahealth Rochester General Hospital
Rochester, New York, 14621, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Brody School of Medicine, East Carolina University
Greenville, North Carolina, 27834, United States
Cardiac, Vascular, & Thoracic Surgeons, Inc.
Cincinnati, Ohio, 45209, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
Oklahoma Cardiovascular Associates
Oklahoma City, Oklahoma, 73120, United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
CardioThoracic Surgery Center, PLC
Jackson, Tennessee, 38301, United States
Jackson Madison County General Hospital
Jackson, Tennessee, 38301, United States
Centennial Medical Center
Nashville, Tennessee, 37203, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Winchester Medical Center
Winchester, Virginia, 22601, United States
FHS Research Center, St. Joseph Medical Center
Tacoma, Washington, 98405, United States
Northwest Cardiovascular Associates
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2006
First Posted
April 20, 2006
Study Start
April 1, 2006
Primary Completion
August 1, 2006
Last Updated
November 18, 2016
Record last verified: 2016-11