Clinical trial NCT00316212: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Coronary Disease
Keywords: Coronary Artery Bypass Graft Surgery involving Cardiopulmonary Bypass
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-04-20
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Postoperative chest drainage volume
Secondary outcomes:
measure: Requirement for perioperative blood product transfusion
measure: Incidence of complications after surgery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Baptist Medical Center Princeton
state: Alabama
city: Birmingham
country: United States
facility: Cardiology, P.C.
state: Alabama
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Springfield
country: United States
facility: Memorial Medical Center
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Fort Wayne
country: United States
facility: Lutheran Hospital of Indiana
state: Indiana
city: Lexington
country: United States
facility: Veterans Affairs Medical Center
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky, Chandler Medical Center
state: Kentucky
city: Saginaw
country: United States
facility: St. Mary's of Michigan
state: Michigan
city: Saginaw
country: United States
facility: Covenant Medical Center
state: Michigan
city: Rochester
country: United States
facility: Viahealth Rochester General Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: The Brody School of Medicine, East Carolina University
state: North Carolina
city: Cincinnati
country: United States
facility: Cardiac, Vascular, & Thoracic Surgeons, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Associates
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Research Group
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Jackson
country: United States
facility: CardioThoracic Surgery Center, PLC
state: Tennessee
city: Jackson
country: United States
facility: Jackson Madison County General Hospital
state: Tennessee
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
city: Tacoma
country: United States
facility: FHS Research Center, St. Joseph Medical Center
state: Washington
city: Tacoma
country: United States
facility: Northwest Cardiovascular Associates
state: Washington
Study officials:
References: