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

Coronary Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00316212
• Other study ID #: 025-102
• Status: Terminated
• Phase: Phase 2
• First received: April 18, 2006
• Last updated: November 17, 2016
• Start date: April 2006

Study information

• Verified date: November 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 160
• Est. primary completion date: August 2006
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Drug:
• INS50589 Intravenous Infusion

Locations

Country	Name	City	State
United States	Baptist Medical Center Princeton	Birmingham	Alabama
United States	Cardiology, P.C.	Birmingham	Alabama
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	Cardiac, Vascular, & Thoracic Surgeons, Inc.	Cincinnati	Ohio
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Lutheran Hospital of Indiana	Fort Wayne	Indiana
United States	The Brody School of Medicine, East Carolina University	Greenville	North Carolina
United States	The Methodist Hospital	Houston	Texas
United States	CardioThoracic Surgery Center, PLC	Jackson	Tennessee
United States	Jackson Madison County General Hospital	Jackson	Tennessee
United States	University of Kentucky, Chandler Medical Center	Lexington	Kentucky
United States	Veterans Affairs Medical Center	Lexington	Kentucky
United States	Centennial Medical Center	Nashville	Tennessee
United States	Oklahoma Cardiovascular Associates	Oklahoma City	Oklahoma
United States	Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	Viahealth Rochester General Hospital	Rochester	New York
United States	Covenant Medical Center	Saginaw	Michigan
United States	St. Mary's of Michigan	Saginaw	Michigan
United States	Sharp Memorial Hospital	San Diego	California
United States	Memorial Medical Center	Springfield	Illinois
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	St. John's Hospital	Springfield	Illinois
United States	FHS Research Center, St. Joseph Medical Center	Tacoma	Washington
United States	Northwest Cardiovascular Associates	Tacoma	Washington
United States	Winchester Medical Center	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative chest drainage volume
Secondary	Requirement for perioperative blood product transfusion
Secondary	Incidence of complications after surgery