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

NCT ID: NCT01083914

Last Updated: 2013-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-09-30

Brief Summary

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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

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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

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Coronary Artery Disease

Keywords

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extracorporeal circulation, off-pump CABG

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Brinkman, MD

Role: PRINCIPAL_INVESTIGATOR

The Heart Hospital at Baylor Plano

Locations

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The Heart Hospital at Baylor Plano

Plano, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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009-113

Identifier Type: -

Identifier Source: org_study_id