Coronary Artery DiseaseNCT01083914
Comparing Blood Loss, RBC Transfusions and Inflammatory Marker Changes Among Methods of CPB
An observational study of Coronary Artery Disease, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital facility
Who may be able to join
- -Males and females at least 18 years of age undergoing CABG surgery who are suitable candidates cardiopulmonary bypass.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Heart Hospital at Baylor Plano
Plano, Texas, 75093
About this study
Official title: 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
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.
Read the detailed description
Off-pump coronary artery bypass grafting (OPCAB) and the use of minimal extracorporeal circulation system (MECC) have both been proposed as alternatives to avoid the harmful effects of conventional cardiopulmonary bypass (CPB). However, with the technically more demanding nature of off-pump CABG, the potential short-term benefits of off-pump surgery may not translate into long-term benefits in providing optimal revascularization. In this prospective cohort study, it is our goal to evaluate short term outcomes as demonstrated by blood loss, transfusion need, and systemic inflammatory response during CABG surgery using MECC or conventional CPB or OPCAB.
In addition to the technical challenges posed during off-pump CABG surgery, it is also known that a significant systemic inflammatory response is mounted in patients who undergo conventional CPB. This inflammatory response is a combined effect of 1) the placement of required tubes and lines for connection with the heart/lung machine, 2) hemodilution, and 3) hypothermia. In this study, we will measure levels of tissue inflammation through the use of specialized laboratory tests (C Reactive Protein, C5 complement activation and Interleukin 6), and we will correlate these inflammation levels to the three different cardiopulmonary bypass options. It is our hypothesis that MECC will provide the stable operating environment of conventional CPB and the patient benefits of less blood loss, decreased transfusion rate, and decreased inflammation levels seen in patients with OPCAB.
Statistical Analysis: Multivariable regression models will be used to investigate the association of the MECC pump, conventional CPB versus off-pump with the outcomes controlling for risk factors recognized by the STS associated with post-CABG adverse outcomes) and other clinical and non-clinical factors. The association of each outcome of interest with MECC versus conventional CPB and MECC versus off-pump will be estimated with 95% confidence intervals (CIs). With a cohort of 102 patients (34 in each of three study groups) we will have over 80% power to detect a 71% relative reduction (30% absolute difference) in transfusion rate among CABG patients using a MECC pump as compared to conventional pump patients assuming that 42% of patients undergoing CABG with conventional pump require a transfusion
- Conditions
- Coronary Artery Disease
- Keywords
- extracorporeal circulation, off-pump CABG
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare blood loss and PRBC transfusions for MECC, OPCAB, and conventional CPB in patients undergoing primary CABG surgery.
Measured: 12 months
Secondary outcomes (5)
To assess survival and readmission rates 30 days post discharge.
Description: Through interview and medical record review subjects will be assessed 30 days post discharge for readmissions, adverse events and survival
Measured: 1 year
To assess and compare levels of tissue inflammation using biomarkers.
Blood samples collected at five timepoints preop, intraop and postoperatively will be evaluated for C-Reactive Protein, C5 Complement Activation and IL-6 levels and compared among the 3 groups.
Measured: 1 year
To assess and compare levels of tissue inflammation using genomic mapping.
Compare blood levels of inflammation by completeing genomic mapping using micrarray technology
Measured: 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.
Measured: 1 year
To use results of the trial to develop a a future large scale trial.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Brinkman, MD, Principal investigator, The Heart Hospital at Baylor Plano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083914
- Sponsor's protocol ID
- 009-113
- Status last verified
- Aug 2013
- First submitted
- 8 Mar 2010
- Last updated
- 23 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01083914
- Acronym / sponsor ID
- 009-113
- Conditions
- Coronary Artery Disease
- Keywords
- extracorporeal circulation, off-pump CABG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Off-pump coronary artery bypass grafting (OPCAB) and the use of minimal extracorporeal circulation system (MECC) have both been proposed as alternatives to avoid the harmful effects of conventional cardiopulmonary bypass (CPB). However, with the technically more demanding nature of off-pump CABG, the potential short-term benefits of off-pump surgery may not translate into long-term benefits in providing optimal revascularization. In this prospective cohort study, it is our goal to evaluate short term outcomes as demonstrated by blood loss, transfusion need, and systemic inflammatory response during CABG surgery using MECC or conventional CPB or OPCAB.
In addition to the technical challenges posed during off-pump CABG surgery, it is also known that a significant systemic inflammatory response is mounted in patients who undergo conventional CPB. This inflammatory response is a combined effect of 1) the placement of required tubes and lines for connection with the heart/lung machine, 2) hemodilution, and 3) hypothermia. In this study, we will measure levels of tissue inflammation through the use of specialized laboratory tests (C Reactive Protein, C5 complement activation and Interleukin 6), and we will correlate these inflammation levels to the three different cardiopulmonary bypass options. It is our hypothesis that MECC will provide the stable operating environment of conventional CPB and the patient benefits of less blood loss, decreased transfusion rate, and decreased inflammation levels seen in patients with OPCAB.
Statistical Analysis: Multivariable regression models will be used to investigate the association of the MECC pump, conventional CPB versus off-pump with the outcomes controlling for risk factors recognized by the STS associated with post-CABG adverse outcomes) and other clinical and non-clinical factors. The association of each outcome of interest with MECC versus conventional CPB and MECC versus off-pump will be estimated with 95% confidence intervals (CIs). With a cohort of 102 patients (34 in each of three study groups) we will have over 80% power to detect a 71% relative reduction (30% absolute difference) in transfusion rate among CABG patients using a MECC pump as compared to conventional pump patients assuming that 42% of patients undergoing CABG with conventional pump require a transfusion
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital facility
Key inclusion criteria (1 listed)
- -Males and females at least 18 years of age undergoing CABG surgery who are suitable candidates cardiopulmonary bypass.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare blood loss and PRBC transfusions for MECC, OPCAB, and conventional CPB in patients undergoing primary CABG surgery.
Time frame: 12 months
5 secondary outcomes
To assess survival and readmission rates 30 days post discharge.
Time frame: 1 year
To assess and compare levels of tissue inflammation using biomarkers.
Time frame: 1 year
To assess and compare levels of tissue inflammation using genomic mapping.
Time frame: 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.
Time frame: 1 year
To use results of the trial to develop a a future large scale trial.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Brinkman, MD principal investigator
The Heart Hospital at Baylor Plano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare blood loss and PRBC transfusions for MECC, OPCAB, and conventional CPB in patients undergoing primary CABG surgery. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2013.