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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01083914
First received: March 8, 2010
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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
Coronary Artery Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • To compare blood loss and PRBC transfusions for MECC, OPCAB, and conventional CPB in patients undergoing primary CABG surgery. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess survival and readmission rates 30 days post discharge. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Description: Through interview and medical record review subjects will be assessed 30 days post discharge for readmissions, adverse events and survival

  • To assess and compare levels of tissue inflammation using biomarkers. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • To assess and compare levels of tissue inflammation using genomic mapping. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Compare blood levels of inflammation by completeing genomic mapping using micrarray technology

  • 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 ] [ Designated as safety issue: No ]
  • To use results of the trial to develop a a future large scale trial. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood


Enrollment: 102
Study Start Date: March 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01083914     History of Changes
Other Study ID Numbers: 009-113
Study First Received: March 8, 2010
Last Updated: August 22, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014