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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.