- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00303641
Safety and Effectiveness of the Medtronic Resting Heart Bypass System in Heart Surgery Patients
A Prospective Randomized Study of the Safety and Effectiveness of the Medtronic Resting Heart System
Study Overview
Status
Intervention / Treatment
Detailed Description
Cardiopulmonary bypass (CPB) has played an extremely crucial role in coronary artery bypass grafting (CABG) surgery for the past five decades. During CABG, the CPB machine enables the surgeon to stop the heart and perform the surgery in a bloodless operating field. The CPB machine essentially takes over the job of the heart by oxygenating the blood and then perfusing the entire body. In patients undergoing CABG surgery with CPB, a systemic inflammatory reaction occurs when the blood is taken out of the body and circulated through the CPB machine. This inflammatory reaction is believed to increase postoperative morbidity and prolong hospital stay. The systemic inflammatory reaction results in activation of the complement, coagulation, fibrinolytic and kallikrein cascades, it activates leukocytes and endothelial cells causing expression of adhesion molecules and results in the release of inflammatory mediators such as cytokines. This inflammatory reaction during CPB leads to vasodilation, increased interstitial fluid and can affect organs such as the heart, lungs, brain and kidneys resulting in their dysfunction(s). Elimination of CPB in patients undergoing CABG surgery has resulted in reduction of this inflammatory response. Unfortunately, not all patients are able to undergo CABG without the use of CPB.
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.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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Ontario
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London, Ontario, Canada, N6A 5A5
- London Health Sciences Centre, University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Consenting patients undergoing elective surgical coronary artery bypass grafting (CABG) with use of the cardiopulmonary bypass machine
Exclusion Criteria:
- Patients unable to provide written informed consent
- Emergency CABG surgery
- Concomitant CABG + Valvular surgery
- Off-pump CABG surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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C-reactive protein
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Cell count
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Cytokine levels
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Complement
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Secondary Outcome Measures
Outcome Measure |
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Postoperative blood loss, units of blood transfused, re-operation for bleeding, chest tube drainage, length of ICU stay, neurologic and renal function, infection, atrial fibrillation and overall length of postoperative hospital stay
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R-04-424
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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