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
  Purpose

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.


Condition Intervention Phase
Coronary Disease
Drug: INS50589 Intravenous Infusion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Postoperative chest drainage volume

Secondary Outcome Measures:
  • Requirement for perioperative blood product transfusion
  • Incidence of complications after surgery

Estimated Enrollment: 160
Study Start Date: April 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316212

  Show 27 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00316212     History of Changes
Other Study ID Numbers: 025-102
Study First Received: April 18, 2006
Last Updated: May 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Coronary Artery Bypass Graft Surgery involving Cardiopulmonary Bypass

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on April 15, 2014