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| [ Print-friendly version ] |
| Autologous bone marrow-derived cells for cardioprotection during heart surgery |
| ISRCTN | ISRCTN22639386 |
| ClinicalTrials.gov identifier | |
| Public title | Autologous bone marrow-derived cells for cardioprotection during heart surgery |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | UHL Ref: 10,176 |
| Study hypothesis |
The principal hypothesis that will be tested is that the administration of autologous Bone Marrow Cells (BMCs) during cardiac surgery can reduce myocardial ischaemic injury and improve cardiac function and clinical outcome. This small clinical trial aims to prove the laboratory concept that autologous BMCs protect the heart against myocardial injury caused by ischaemia and serve as a base for a large trial aimed at investigating whether BMCs improve the clinical outcomes and have an impact on the costing of care.
The specific objectives of this project are: 1. To investigate in a randomised, double-blinded study whether the administration of autologous bone marrow cells as an additive to cardioplegia reduces myocardial ischaemic injury during cardiac surgery. 2. To study whether the administration of autologous BMCs improves cardiac function during the early period following cardiac surgery. |
| Ethics approval | Under review at present. |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Ischaemic heart disease |
| Participants - inclusion criteria |
1. Triple vessel coronary artery disease with or without significant disease of the left main stem with indication of elective surgical revascularisation
2. Left ventricular ejection fraction greater than 40% 3. Age 20 to 80 years |
| Participants - exclusion criteria |
In addition to not being compliant to the inclusion criteria, the following criteria will be sufficient to exclude patients from entering the study:
1. Cardiogenic shock (need for inotropic drugs, intra-aortic balloon pump) 2. Previous Coronary Artery Bypass Graft (CABG) 3. Percutaneous Coronary Infusion (PCI) in the previous three months 4. History of neoplastic disease 5. History of bleeding disorder 6. Chronic inflammatory disease 7. Active infection 8. Renal impairment (creatinine more than 180 mmol/l) 9. Liver dysfunction (Glutamate Oxalate Transferase [GOT] more than 2 x Upper Limit of Normal [ULN] or International Normalised Ratio [INR] more than 1.5 x ULN) 10. Diabetes 11. Chronic treatment with oral antibiotic agents |
| Anticipated start date | 03/01/2007 |
| Anticipated end date | 03/07/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 44 (22 in bone marrow group, 22 in control group) |
| Interventions |
Patients with triple vessel coronary artery disease with or without associated significant disease of the left main stem and undergoing elective CABG surgery will be recruited for the study. Patients will be randomised at the time of surgery to either of the following study groups:
1. Group I: control - receiving serum alone 2. Group II: receiving BMCs at then end of the first dose of cardioplegia and then at the end of each new dose of cardioplegia Autologous BMCs (diluted in 10 mL of autologous serum) will be administered into the aortic root at the end of cardioplegia infusion (last 20 mL of cardioplegia to ascertain that BMCs remain within the coronary vasculature during the ensuing ischaemic period) or the equivalent amount of serum to act as control. Blood cardioplegia will be used with an initial dose of 1 L and 0.5 L following the completion of each coronary anastomosis, usually every 15 - 20 minutes. Blood samples will be taken before surgery and four, 12, 24 and 48 hours after surgery for determination of plasma levels of troponin I. An Electrocardiogram (ECG) will be recorded before surgery and at four and 24 hours for the identification of new electrical ischaemic changes. A Swan-Ganz catheter will be floated into the pulmonary artery during the induction of anaesthesia for the assessment of cardiac function (cardiac index and stroke volume index) before surgery and 30 minutes, one, two, four, eight, 12, and 24 hours after surgery. Cardiac filling pressures (central venous pressure between 8 and 12 mmHg and pulmonary capillary wedge pressure between 12 and 16 mmHg with appropriate transfusion), heart rate (between 70 and 90 beats/minute with atrioventricular pacing if required) and systemic vascular resistance index (between 1200 and 1800 units using vasodilators such as Glyceryl Trinitrate [GTN] and vasoconstrictors as vasopressin if required) will be kept within the physiological range. Hospital mortality, the need for inotropic drugs (dopamine more than 10 mg/Kg/min and any other inotropic drug) or intra-aortic balloon pump to support cardiac function and the presence of severe cardiac arrhythmias requiring cardioversion or the use of anti-arrhythmic drugs will be recorded. |
| Primary outcome measure(s) | Troponin I in plasma |
| Secondary outcome measure(s) |
1. Left ventricular function
2. Composite clinical outcome |
| Sources of funding | Cardiac Surgery Group (UK) - a specific group within the University of Leicester and Glenfield Hospital |
| Trial website | |
| Publications |
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15040600
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17059931 |
| Contact name | Prof Manuel Galinanes |
| Address |
Cardiac Surgery Group
Department of Cardiovascular Sciences Clinical Science Wing Glenfield Hospital Groby Road |
| City/town | Leicester |
| Zip/Postcode | LE3 9QP |
| Country | United Kingdom |
| Tel | +44 (0)116 256 3031 |
| Fax | +44 (0)116 250 2449 |
| mg50@le.ac.uk | |
| Sponsor | University Hospitals of Leicester NHS Trust (UK) |
| Address |
Trust Headquarters
Gwendolen House Gwendolen Road |
| City/town | Leicester |
| Zip/Postcode | LE5 4QF |
| Country | United Kingdom |
| Tel | +44 (0)116 258 4199 |
| Fax | +44 (0)116 258 4556 |
| djr8@le.ac.uk | |
| Sponsor website: | http://www.uhl-tr.nhs.uk/about-us/contact-us/uhl-hq |
| Date applied | 01/12/2006 |
| Last edited | 04/10/2007 |
| Date ISRCTN assigned | 14/02/2007 |
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| © 2010 ISRCTN unless otherwise stated. | |
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