Autologous Bone Marrow-Derived Cells for Cardioprotection During Heart Surgery - Bone Marrow Cells & Cardioprotectio
- Conditions
- Improvement of cardioprotection during elective coronary artery bypass graft surgery using the patients own bone marrow cells.
- Registration Number
- EUCTR2006-006480-23-GB
- Lead Sponsor
- niversity Hospitals of Leicester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 44
•Triple vessel coronary artery disease with or without significant disease of the left main stem with indication of elective surgical revascularization
•Left ventricular ejection fraction greater than 40%
•Age 20-80 years
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
In addition to not being compliant to the inclusion criteria, the following criteria will be sufficient to exclude patients from entering the study:
•Cardiogenic shock (need for inotropic drugs, intra-aortic balloon pump)
•Previous CABG
•PCI in the previous 3 months
•History of neoplastic disease
•History of bleeding disorder
•Chronic inflammatory disease
•Active infection
•Renal impairment (creatinine >180mmol/l)
•Liver dysfunction (GOT >2xULN or INR >1.5)
•Diabetes
•Chronic treatment with oral antibiotic agents
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method