Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123981
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2005-07-25
Brief Title:
The Danish On-pump Off-pump Randomization Study DOORS
Sponsor:
Kim Houlind
Organization:
Odense University Hospital
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
Conventional coronary artery bypass grafting CCABG using cardiopulmonary bypass has for decades been applied to obtain myocardial re-vascularisation and hence improved quality of life and survival It does however bear a risk of death stroke myocardial infarction and other serious complications
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None