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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014