The Danish On-pump, Off-pump Randomization Study (DOORS)
NCT ID: NCT00123981
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
900 participants
INTERVENTIONAL
2005-01-31
2011-01-31
Brief Summary
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The aim of the present study is to compare the incidence of complications and the clinical efficacy of CABG with and without the use of CPB in elderly patients.
Detailed Description
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During recent years, an equivalent operation performed on the beating heart without cardiopulmonary bypass (off-pump coronary artery bypass grafting, OPCAB) has gained popularity helped by the advent of mechanical stabilization devices and improved surgical techniques. Observational studies suggest that this technique is associated with a lower incidence of stroke, per operative arrhythmias and even mortality than conventional CCABG. This is especially the case in elderly patients and patients with significant co-morbidity.
Only few randomised, controlled trials have been conducted and most of these included mainly or only low-risk, relatively young patients. These studies have documented the safety and efficacy of OPCAB compared with CCABG, but none of the trials has had the statistical strength to determine whether the rate of serious complications is lower after OPCAB operations. One recent study found graft patency to be significantly lower after OPCAB than after CCABG operations.
The investigators find that there is a need of a larger scale randomised trial to compare the results of CCABG and OPCAB operations, especially in elderly patients. This patient group is poorly represented in earlier randomised trials, whereas observational studies and theoretical considerations imply that they may benefit the most from avoiding cardiopulmonary bypass.
Aims: Primarily, to compare the incidence of death, stroke and myocardial infarction after CCABG and OPCAB procedures in a population of elderly patients. Furthermore, to compare quality of life and graft patency, and cost- effectiveness after CCABG and OPCAB.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CCABG
Coronary artery bypass surgery using cardiopulmonary bypass
Off-Pump Coronary Artery Bypass Grafting
OPCAB
Coronary artery bypass surgery NOT using cardiopulmonary bypass
Off-Pump Coronary Artery Bypass Grafting
Interventions
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Off-Pump Coronary Artery Bypass Grafting
Eligibility Criteria
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Inclusion Criteria
* Admitted for first time coronary artery bypass operation
Exclusion Criteria
* Aortic crossclamping not safe due to calcification
* Preoperative cardiac conditions demanding cardiopulmonary bypass
* Re-do cardiac surgery
* Patients requiring operation within the same day after conference
70 Years
ALL
No
Sponsors
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Kim Houlind
OTHER
Responsible Party
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Kim Houlind
Senior consultant, Associate Professor
Principal Investigators
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Kim C Houlind, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Poul E Mortensen, MD
Role: STUDY_CHAIR
Odense University Hospital
Locations
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Dept. of Cardiothoracic and Vascular Surgery, Skejby Sygehus, Aarhus University Hospital
Aarhus, Aarhus, Denmark
Countries
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References
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Houlind KC, Kjeldsen BJ, Terp KA, Madsen SN, Schmidt TA, Holme SJ, Mortensen PE. [Coronary artery bypass surgery without the use of a heart-lunch machine]. Ugeskr Laeger. 2005 May 9;167(19):2037-41. No abstract available. Danish.
Houlind K, Fenger-Gron M, Holme SJ, Kjeldsen BJ, Madsen SN, Rasmussen BS, Jepsen MH, Ravkilde J, Aaroe J, Hansen PR, Hansen HS, Mortensen PE; DOORS Study Group. Graft patency after off-pump coronary artery bypass surgery is inferior even with identical heparinization protocols: results from the Danish On-pump Versus Off-pump Randomization Study (DOORS). J Thorac Cardiovasc Surg. 2014 Nov;148(5):1812-1819.e2. doi: 10.1016/j.jtcvs.2014.02.024. Epub 2014 Feb 8.
Houlind K, Kjeldsen BJ, Madsen SN, Rasmussen BS, Holme SJ, Nielsen PH, Mortensen PE; DOORS Study Group. On-pump versus off-pump coronary artery bypass surgery in elderly patients: results from the Danish on-pump versus off-pump randomization study. Circulation. 2012 May 22;125(20):2431-9. doi: 10.1161/CIRCULATIONAHA.111.052571. Epub 2012 Apr 20.
Houlind K, Kjeldsen BJ, Madsen SN, Rasmussen BS, Holme SJ, Schmidt TA, Haahr PE, Mortensen PE; DOORS study group. The impact of avoiding cardiopulmonary by-pass during coronary artery bypass surgery in elderly patients: the Danish On-pump Off-pump Randomisation Study (DOORS). Trials. 2009 Jul 4;10:47. doi: 10.1186/1745-6215-10-47.
Related Links
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home page of the Danish Heart Foundation
Other Identifiers
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DTS-0001
Identifier Type: -
Identifier Source: org_study_id