Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Grafting (CABG) Involving Cardiopulmonary Bypass
Overview
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.
Full Title of Study: “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
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Double
- Study Primary Completion Date: August 2006
Interventions
- Drug: INS50589 Intravenous Infusion
Clinical Trial Outcome Measures
Primary Measures
- Postoperative chest drainage volume
Secondary Measures
- Requirement for perioperative blood product transfusion
- Incidence of complications after surgery
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Investigator Details
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Provider of Information About this Clinical Study
- Sponsor
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