Cardiopulmonary Bypass Clinical Trial
Official title:
A Prospective Randomized Study of the Safety and Effectiveness of the Medtronic Resting Heart System
Verified date | August 2017 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if the Medtronic Resting Heart Bypass system is safer and results in less inflammatory reaction than traditional bypass machines used in coronary artery bypass surgery. We hypothesize that the new Medtronic Resting Heart System is safer and results in much less systemic inflammatory reaction in comparison to the standard cardiopulmonary bypass systems currently in use.
Status | Completed |
Enrollment | 60 |
Est. completion date | February 2006 |
Est. primary completion date | November 2005 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre, University Hospital | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute | Medtronic |
Canada,
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. — View Citation
Edmunds LH Jr. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg. 1998 Nov;66(5 Suppl):S12-6; discussion S25-8. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Matata BM, Sosnowski AW, Galiñanes M. Off-pump bypass graft operation significantly reduces oxidative stress and inflammation. Ann Thorac Surg. 2000 Mar;69(3):785-91. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | C-reactive protein | |||
Primary | Cell count | |||
Primary | Cytokine levels | |||
Primary | Complement | |||
Secondary | 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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