NCT00303641

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

March 15, 2006

Last Update Submit

August 25, 2017

Conditions

Coronary Artery Bypass SurgeryCardiopulmonary Bypass

Keywords

Cardiopulmonary bypassInflammatory reaction

Outcome Measures

Primary Outcomes (4)

  • C-reactive protein

  • Cell count

  • Cytokine levels

  • Complement

Secondary Outcomes (1)

  • 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

Interventions

Medtronic Resting Heart Bypass SystemDEVICE

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consenting patients undergoing elective surgical coronary artery bypass grafting (CABG) with use of the cardiopulmonary bypass machine

You may not qualify if:

  • Patients unable to provide written informed consent
  • Emergency CABG surgery
  • Concomitant CABG + Valvular surgery
  • Off-pump CABG surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre, University Hospital

London, Ontario, N6A 5A5, Canada

Location

Related Publications (9)

  • 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.

    PMID: 6606084BACKGROUND

  • 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.

    PMID: 14690730BACKGROUND

  • 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.

    PMID: 9869435BACKGROUND

  • 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.

    PMID: 10750762BACKGROUND

  • 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.

    PMID: 9485239BACKGROUND

  • 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.

    PMID: 9596308BACKGROUND

  • 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.

    PMID: 12694789BACKGROUND

  • 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.

    PMID: 11986603BACKGROUND

  • 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.

    PMID: 12607672BACKGROUND

Related Links

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bob Kiaii, MD, FRCSC

    Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre, University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2006

First Posted

March 17, 2006

Study Start

November 1, 2004

Primary Completion

November 1, 2005

Study Completion

February 1, 2006

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations

CA(1)