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

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00316212
First received: April 18, 2006
Last updated: May 24, 2013
Last verified: May 2013

April 18, 2006
May 24, 2013
April 2006
August 2006   (final data collection date for primary outcome measure)
Postoperative chest drainage volume
Same as current
Complete list of historical versions of study NCT00316212 on ClinicalTrials.gov Archive Site
  • Requirement for perioperative blood product transfusion
  • Incidence of complications after surgery
Same as current
Not Provided
Not Provided
 
Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Grafting (CABG) Involving Cardiopulmonary Bypass
Randomized, Multicenter, Placebo-Controlled, Double-Blind, Parallel Group Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Graft Surgery Involving Cardiopulmonary Bypass

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Coronary Disease
Drug: INS50589 Intravenous Infusion
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
160
Not Provided
August 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00316212
025-102
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP