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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Coronary Disease

Treatments: Drug: INS50589 Intravenous Infusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00316212

025-102

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind