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

NCT ID: NCT00316212

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Disease

Keywords

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Coronary Artery Bypass Graft Surgery involving Cardiopulmonary Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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INS50589 Intravenous Infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Baptist Medical Center Princeton

Birmingham, Alabama, United States

Site Status

Cardiology, P.C.

Birmingham, Alabama, United States

Site Status

Sharp Memorial Hospital

San Diego, California, United States

Site Status

Memorial Medical Center

Springfield, Illinois, United States

Site Status

St. John's Hospital

Springfield, Illinois, United States

Site Status

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

Lutheran Hospital of Indiana

Fort Wayne, Indiana, United States

Site Status

Veterans Affairs Medical Center

Lexington, Kentucky, United States

Site Status

University of Kentucky, Chandler Medical Center

Lexington, Kentucky, United States

Site Status

St. Mary's of Michigan

Saginaw, Michigan, United States

Site Status

Covenant Medical Center

Saginaw, Michigan, United States

Site Status

Viahealth Rochester General Hospital

Rochester, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

The Brody School of Medicine, East Carolina University

Greenville, North Carolina, United States

Site Status

Cardiac, Vascular, & Thoracic Surgeons, Inc.

Cincinnati, Ohio, United States

Site Status

Good Samaritan Hospital

Cincinnati, Ohio, United States

Site Status

Bethesda North Hospital

Cincinnati, Ohio, United States

Site Status

Oklahoma Cardiovascular Associates

Oklahoma City, Oklahoma, United States

Site Status

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, United States

Site Status

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, United States

Site Status

CardioThoracic Surgery Center, PLC

Jackson, Tennessee, United States

Site Status

Jackson Madison County General Hospital

Jackson, Tennessee, United States

Site Status

Centennial Medical Center

Nashville, Tennessee, United States

Site Status

The Methodist Hospital

Houston, Texas, United States

Site Status

Winchester Medical Center

Winchester, Virginia, United States

Site Status

FHS Research Center, St. Joseph Medical Center

Tacoma, Washington, United States

Site Status

Northwest Cardiovascular Associates

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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025-102

Identifier Type: -

Identifier Source: org_study_id