ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparing Blood Loss, RBC Transfusions and Inflammatory Marker Changes Among Methods of CPB

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01083914
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : August 23, 2013
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

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.

Condition or disease
Coronary Artery Disease

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 Type : Observational
Actual Enrollment : 102 participants
Observational Model: Case Control
Time Perspective: Prospective
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
Study Start Date : March 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Group/Cohort
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



Primary Outcome Measures :
  1. To compare blood loss and PRBC transfusions for MECC, OPCAB, and conventional CPB in patients undergoing primary CABG surgery. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. To assess survival and readmission rates 30 days post discharge. [ Time Frame: 1 year ]
    Description: Through interview and medical record review subjects will be assessed 30 days post discharge for readmissions, adverse events and survival

  2. To assess and compare levels of tissue inflammation using biomarkers. [ Time Frame: 1 year ]
    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.

  3. To assess and compare levels of tissue inflammation using genomic mapping. [ Time Frame: 1 year ]
    Compare blood levels of inflammation by completeing genomic mapping using micrarray technology

  4. 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 ]
  5. To use results of the trial to develop a a future large scale trial. [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital facility
Criteria

Inclusion Criteria:

-Males and females at least 18 years of age undergoing CABG surgery who are suitable candidates cardiopulmonary bypass.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083914


Locations
United States, Texas
The Heart Hospital at Baylor Plano
Plano, Texas, United States, 75093
Sponsors and Collaborators
Baylor Research Institute
Investigators
Principal Investigator: William Brinkman, MD The Heart Hospital at Baylor Plano

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01083914     History of Changes
Other Study ID Numbers: 009-113
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: August 23, 2013
Last Verified: August 2013

Keywords provided by Baylor Research Institute:
extracorporeal circulation, off-pump CABG

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases