Comparing Blood Loss, RBC Transfusions and Inflammatory Marker Changes Among Methods of CPB
Investigation of the Ability of the MECC System to Provide Reduced Risk Over the Existing CECC System and Equivalent Risk to Off-Pump CABG Surgery: The IMPROVE TRIAL
1 other identifier
observational
102
1 country
1
Brief Summary
The purpose of this study is to compare blood loss and the number of transfusions received by each patient having coronary bypass surgery. The second purpose is to determine how the level inflammation in patients during and after surgery may affect a patient's response to surgery and the recovery process.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2010
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
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 8, 2010
CompletedFirst Posted
Study publicly available on registry
March 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedAugust 23, 2013
August 1, 2013
1.5 years
March 8, 2010
August 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare blood loss and PRBC transfusions for MECC, OPCAB, and conventional CPB in patients undergoing primary CABG surgery.
12 months
Secondary Outcomes (5)
To assess survival and readmission rates 30 days post discharge.
1 year
To assess and compare levels of tissue inflammation using biomarkers.
1 year
To assess and compare levels of tissue inflammation using genomic mapping.
1 year
To identify a definition of a genomic signature of inflammation that predicts best outcomes in using CECC, MECC, and off-pump for CABG surgery.
1 year
To use results of the trial to develop a a future large scale trial.
2 years
Study Arms (3)
OPCAB
Those who have CABG surgery off pump Those who have CABG surgery using conventional cardiopulmonary bypass Those who have CABG surgery using a minimal extracorporeal circulation system
CPB
Those who have CABG surgery off pump Those who have CABG surgery using conventional cardiopulmonary bypass Those who have CABG surgery using a minimal extracorporeal circulation system
MECC
Those who have CABG surgery off pump Those who have CABG surgery using conventional cardiopulmonary bypass Those who have CABG surgery using a minimal extracorporeal circulation system
Eligibility Criteria
Hospital facility
You may qualify if:
- Males and females at least 18 years of age undergoing CABG surgery who are suitable candidates cardiopulmonary bypass.
You may not qualify if:
- Candidate requires emergency surgery.
- Previous cardiac surgery.
- Plans for concomitant cardiac valve surgery. (Note: concomitant vein isolation is permissible).
- Pregnant or intends to become pregnant during the study.
- Candidate is unable or unwilling to provide informed consent participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Heart Hospital at Baylor Plano
Plano, Texas, 75093, United States
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Brinkman, MD
The Heart Hospital at Baylor Plano
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2010
First Posted
March 10, 2010
Study Start
March 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
August 23, 2013
Record last verified: 2013-08