Primary cardiac surgery involving cardiopulmonary bypass
Conditions
Interventions
Product Name: MDCO-2010
Product Code: MDCO-2010
Pharmaceutical Form: Infusion
Current Sponsor code: MDCO-2010
Other descriptive name: 3-HOOC-Bzls-D-Ppg-Phe(3-Ame)-4-Amba acetate
Concentration unit: %
Sponsors
The Medicines Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • In Stage 1: Planned primary isolated CABG surgery • In Stage 2: Planned primary isolated CABG surgery, OR Planned primary combined CABG and aortic valve replacement surgery • Men, aged 18 to 85 years, OR Women, aged 18 to 85 years, either of postmenopausal status, defined as =1 year since last menstrual period, or with a medical history of hysterectomy or bilateral oophorectomy •Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 135 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 135
Exclusion criteria
Exclusion criteria: • Off-pump surgery or hybrid procedures • Patients undergoing repeat sternotomy • Planned deep hypothermic circulatory arrest (35 • Known active gastrointestinal (GI) or other non-catheterization bleeding within 7 days prior to surgery • Preoperative coagulation abnormalities defined as: – Platelet count 350,000/?L, or – International normalized ratio (INR) >1.5, or – Hematocrit 1.5 x the upper limit of normal (ULN) • Major surgical procedures within 30 days prior to surgery • Patient inability or refusal to receive donor blood products if necessary • Creatinine >2 mg/dL or estimated glomerular filtration rate (eGFR) (calculated using Modification of Diet in Renal Disease [MDRD] equation) <30 mL/min • Known heparin-induced thrombocytopenia type II • Known history of thrombophilia, such as AT-III, Protein C or Protein S deficiency, Factor V Leiden, anti-phospholipid syndrome • Known active liver disease • Any condition requiring ongoing chronic immunosuppressive medication • Malignancy within 5 years prior to surgery • Receipt of an investigational drug or device within 60 days prior to surgery • Any other condition which, in the opinion of the Principal Investigator, would put the subject at increased risk from participating in the study or otherwise prevent a patient’s participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: safety;Primary end point(s): • Chest tube drainage 12 hours after surgery;Timepoint(s) of evaluation of this end point: 12 hours after surgery;Main Objective: The objective of this study is to determine the dose response relationship regarding blood loss, pharmacokinetics (PK), pharmacodynamics (PD), safety and clinical outcomes of MDCO-2010 vs. placebo and tranexamic acid in patients undergoing primary cardiac surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: • Chest tube drainage at 6 and 24 hours postoperatively • Avoidance of any transfusions • Incidence of massive postoperative transfusion, defined as >5 units of red blood cells (RBCs) within 24 hours postoperatively • Number of allogeneic blood product (RBC, FFP or PC) units transfused within 24 hours postoperatively • Incidence of re-sternotomy for bleeding or cardiac tamponade within 24 hours postoperatively • Incidence of requirement for mechanical ventilation longer than 24 hours postoperatively • Time to extubation • Length of intensive care unit (ICU) stay Safety: • Occurrence of death within 30 days post-treatment • Occurrence of myocardial infarction within 30 days post-treatment • Occurrence of stroke within 30 days post-treatment • Incidence of convulsive seizures within 7 days post-treatment • Incidence of deep vein thrombosis or pulmonary embolism within 7 days post-treatment • Incidence of acute kidney injury • Incidence of clinically significant biomarker changes indicative of renal (creatinine), cardiac (troponin) and hepatic (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [Alk P] and bilirubin) function • All adverse events (AEs) and serious adverse events (SAEs) Pharmacokinetic and pharmacodynamic: • Pharmacokinetic – MDCO-2010 plasma and urine concentrations to calculate PK parameters • Pharmacodynamic – D-dimer – aPTT and ACT ;Timepoint(s) of evaluation of this end point: throughout treatment and follow-up | — |
Countries
Canada, Germany, Switzerland, United States
Contacts
Public ContactManaging Director
The Medicines Company (Leipzig) GmbH
Outcome results
None listed