Coronary Disease
Conditions
Keywords
Coronary Artery Bypass Graft Surgery involving Cardiopulmonary Bypass
Brief summary
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.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative chest drainage volume | — |
Secondary
| Measure | Time frame |
|---|---|
| Requirement for perioperative blood product transfusion | — |
| Incidence of complications after surgery | — |
Countries
United States
Outcome results
None listed