The Danish On-pump, Off-pump Randomization Study (DOORS)
The Impact of Avoiding Cardiopulmonary By-pass During Coronary Artery Bypass Surgery for Ischemic Heart Disease in Elderly Patients: The Danish On-pump, Off-pump Randomization Study (DOORS)
1 other identifier
interventional
900
1 country
1
Brief Summary
Background: Coronary artery bypass grafting (CABG) can be performed either with or without the use of cardiopulmonary bypass (CPB) to obtain myocardial re-vascularisation. The investigators hypothesize that CABG without the use of CPB may reduce the risk of perioperative death, stroke, myocardial infarction and other serious complications. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 25, 2005
CompletedFirst Posted
Study publicly available on registry
July 26, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedNovember 6, 2013
November 1, 2013
3.8 years
July 25, 2005
November 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A combined endpoint of death + stroke + myocardial infarction within 30 days from operation
30 days
Secondary Outcomes (6)
A combined endpoint of death + stroke + myocardial infarction during follow-up
3 years
Patency of bypass grafts assessed by coronary angiography 6 months after the operation
6 months
Total mortality and cardiac mortality during follow-up
3 years
Need of new intervention for cardiac angina during follow-up
3 years
Quality of life assessed by MOS SF-36 and EuroQol questionnaires 6 months and 3 years after the operation
6 months and 3 years
- +1 more secondary outcomes
Study Arms (2)
CCABG
ACTIVE COMPARATORCoronary artery bypass surgery using cardiopulmonary bypass
OPCAB
EXPERIMENTALCoronary artery bypass surgery NOT using cardiopulmonary bypass
Interventions
Eligibility Criteria
You may qualify if:
- Age seventy years or above
- Admitted for first time coronary artery bypass operation
You may not qualify if:
- Given information cannot be understood
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kim Houlindlead
Study Sites (1)
Dept. of Cardiothoracic and Vascular Surgery, Skejby Sygehus, Aarhus University Hospital
Aarhus, Aarhus, 8200, Denmark
Related Publications (4)
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.
PMID: 15960455BACKGROUNDHoulind 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.
PMID: 24613160DERIVEDHoulind 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.
PMID: 22523305DERIVEDHoulind 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.
PMID: 19575814DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kim C Houlind, MD, PhD
Aarhus University Hospital
- STUDY CHAIR
Poul E Mortensen, MD
Odense University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Senior consultant, Associate Professor
Study Record Dates
First Submitted
July 25, 2005
First Posted
July 26, 2005
Study Start
January 1, 2005
Primary Completion
November 1, 2008
Study Completion
January 1, 2011
Last Updated
November 6, 2013
Record last verified: 2013-11