Safety and Effectiveness of the Medtronic Resting Heart Bypass System in Heart Surgery Patients
NCT ID: NCT00303641
Last Updated: 2017-08-28
Study Results
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Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2004-11-30
2006-02-28
Brief Summary
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Detailed Description
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Most conventional CPB systems also use cardiotomy suction which returns all the blood collected in the operative field back to the CPB reservoir and then eventually returns it to the patient. This blood is rich in inflammatory mediators and small particles because it has been activated by surgical trauma and by the proteins lining the wound cavity. Returning this blood back into the CPB circuit results in further circulation of inflammatory mediators. Removal of the cardiotomy suction from the CPB system could potentially decrease the inflammatory mediators and reduce the inflammatory response during CPB.
Recently, there have been attempts to decrease the inflammatory reaction caused by the use of CPB by developing better, more effective systems. The Medtronic Resting Heart System is very similar to conventional CPB systems and has been approved for clinical use both in Canada and the United States. It has some potential advantages over traditional bypass machines which include; 1)a fully closed-to-air system that does not allow an air-blood interface which could prevent blood activation, 2)it does not have cardiotomy suction and therefore prevents air, lipids or particulate emboli from being re-introduced into the patient's circulation, 3)it minimizes hemodilution by using smaller and low-prime circuits, possibly decreasing the need for postoperative blood transfusion, 4)the CPB circuit, which is the blood-contacting surface, is coated with Carmeda Bioactive Surface (a heparin bioactive surface), that mimics critical characteristics of vascular endothelium and may prevent further blood activation, and 5)it has an active venous air detector and removal device (VARD) that detects venous air and automatically removes the air which may prevent blood activation. All of these elements are potential benefits which may further reduce the morbidity and inflammation associated with CABG surgery.
Thus far to our knowledge, there have been no studies looking at the inflammatory reaction and morbidity in patients undergoing CABG procedures using more improved cardiopulmonary bypass machines. We are therefore proposing a prospective, randomized trial of the safety and effectiveness of the Medtronic Resting Heart system in CABG surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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Medtronic Resting Heart Bypass System
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Emergency CABG surgery
* Concomitant CABG + Valvular surgery
* Off-pump CABG surgery
30 Years
85 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Principal Investigators
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Bob Kiaii, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre, University Hospital
Locations
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London Health Sciences Centre, University Hospital
London, Ontario, Canada
Countries
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References
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Kirklin JK, Westaby S, Blackstone EH, Kirklin JW, Chenoweth DE, Pacifico AD. Complement and the damaging effects of cardiopulmonary bypass. J Thorac Cardiovasc Surg. 1983 Dec;86(6):845-57.
Wehlin L, Vedin J, Vaage J, Lundahl J. Activation of complement and leukocyte receptors during on- and off pump coronary artery bypass surgery. Eur J Cardiothorac Surg. 2004 Jan;25(1):35-42. doi: 10.1016/s1010-7940(03)00652-3.
Edmunds LH Jr. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg. 1998 Nov;66(5 Suppl):S12-6; discussion S25-8. doi: 10.1016/s0003-4975(98)00967-9.
Matata BM, Sosnowski AW, Galinanes M. Off-pump bypass graft operation significantly reduces oxidative stress and inflammation. Ann Thorac Surg. 2000 Mar;69(3):785-91. doi: 10.1016/s0003-4975(99)01420-4.
Gu YJ, Mariani MA, van Oeveren W, Grandjean JG, Boonstra PW. Reduction of the inflammatory response in patients undergoing minimally invasive coronary artery bypass grafting. Ann Thorac Surg. 1998 Feb;65(2):420-4. doi: 10.1016/s0003-4975(97)01127-2.
Fransen E, Maessen J, Dentener M, Senden N, Geskes G, Buurman W. Systemic inflammation present in patients undergoing CABG without extracorporeal circulation. Chest. 1998 May;113(5):1290-5. doi: 10.1378/chest.113.5.1290.
Jewell AE, Akowuah EF, Suvarna SK, Braidley P, Hopkinson D, Cooper G. A prospective randomised comparison of cardiotomy suction and cell saver for recycling shed blood during cardiac surgery. Eur J Cardiothorac Surg. 2003 Apr;23(4):633-6. doi: 10.1016/s1010-7940(02)00834-5.
Aldea GS, Soltow LO, Chandler WL, Triggs CM, Vocelka CR, Crockett GI, Shin YT, Curtis WE, Verrier ED. Limitation of thrombin generation, platelet activation, and inflammation by elimination of cardiotomy suction in patients undergoing coronary artery bypass grafting treated with heparin-bonded circuits. J Thorac Cardiovasc Surg. 2002 Apr;123(4):742-55. doi: 10.1067/mtc.2002.120347.
Kaza AK, Cope JT, Fiser SM, Long SM, Kern JA, Kron IL, Tribble CG. Elimination of fat microemboli during cardiopulmonary bypass. Ann Thorac Surg. 2003 Feb;75(2):555-9; discussion 559. doi: 10.1016/s0003-4975(02)04540-x.
Related Links
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London Health Sciences Centre, University Hospital, Division of Cardiac Surgery
Other Identifiers
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R-04-424
Identifier Type: -
Identifier Source: org_study_id
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