This trial will involve approximately 42 patients requiring coronary artery bypass graft surgery (CABG).
Conditions
Interventions
Trade Name: Angiomax
Product Name: bivalirudin
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: bivalirudin
CAS Number: 128270-60-0
Current Sponsor code: Angiox, Angiomax, H
Sponsors
The Medicines Company UK Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Provide written informed consent before the initiation of any study related procedures. • Be at least 18 years of age. • Be scheduled for a non-emergent CABG, CABG and single valve surgery, or isolated single valve surgery on CPB under normothermic conditions. Patients undergoing repeat CABG or repeat single valve are also eligible for this study. • Have a creatinine clearance > 30 ml/min • Have a left ventricular ejection fraction > 30%. Are the trial subjects under 18? 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will not be included in this study if they have or have had: • A cerebrovascular accident within 6 months or any cerebrovascular accident with a residual neurological deficit. • A confirmed pregnancy at time of enrollment. (Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrolment, nursing mothers will also be excluded. Women of childbearing potential must use an acceptable form of birth control (oral contraceptives or estrogen-eluting intrauterine device)). • An intracranial neoplasm, arteriovenous malformation or aneurysm. • A dependency on renal dialysis or creatinine clearance 1) double (or greater) valve repair-replacement (e.g.: AVR-MVR) surgery. • Known allergy to aprotinin (Trasylol®), or known sensitivity to any component of the product. • Received aprotinin (Trasylol®) within the previous 6 months of enrollment. Patients excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed. - Active bleeding or increased risk of bleeding due to hemostasis disorders and/or irreversible coagulation disorders -Severe uncontrolled hypertension and subacute bacterial endocarditis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to characterise the conditions for the elimination of bivalirudin through the use of zero balanced modified ultra-filtration (ZBMUF) after separation from cardiopulmonary bypass (CPB) in patients undergoing coronary artery bypass graft surgery (CABG). An additional objective of the study is to understand the effect of high dose aprotinin during constant bivalirudin infusion after CPB under standardised conditions.;Secondary Objective: ;Primary end point(s): This is a pharmacokinetic study. The criteria for evaluation are: • plasma levels of bivalirudin during constant infusion termination and separation from CPB. • The effectiveness of post-operative hemofiltration on bivalirudin elimination. • Functional assessments of anticoagulation during and after CPB. • Bivalirudin plasma levels during high dose aprotinin administration during and after CPB independent of any influence from hemofiltration. • Duration of surgery, duration of CPB and time from end of CPB to skin closure or end of surgery will be assessed. | — |
Countries
Germany
Outcome results
None listed