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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.

2014-08-27 03:15:19 | BioPortfolio

Summary

The primary aim of this data collection is a three way comparison of the Maquet Minimal Extra-Corporeal Circulation (M.E.C.C.) system to the conventional cardiopulmonary bypass system to off-pump surgery in the setting of coronary artery bypass grafting. The primary point of comparison will be patient blood loss (intra-operative measurements combined with total blood loss via chest tube drains) and total number of units of packed red blood cells received by each patient type during surgery and throughout the post-operative inpatient course.

Description

Literature illustrates that concerns exist regarding the technically demanding nature of off-pump coronary artery bypass (OPCAB) procedures, as well as the quality of anastomoses associated with it, the difficulty in achieving complete revascularization, and the lack of proven clinical benefit. Short-term clinical outcomes of MECC - CABG patients are satisfactory. Compared to CECC - CABG, the need for transfusion is significantly reduced when a MECC is used. Oxidative stress parameters show a tendency towards improved global organ protection compared to CECC - CABG. Research has also shown advantages associated with the MECC system in regards to alveolar stress during surgery, as well as lower concentrations of inflammatory markers during surgery. This study will provide information that will illustrate whether or not correlations exist between the type of CABG surgery performed, the inflammatory markers present at certain times pre-, intra-, and post-operatively,blood loss associated with a certain type of CABG surgery, and potentially any further correlations that may exist within the subject population. Analysis of the data obtained from this trial will ideally provide opportunities for other studies regarding information obtained throughout the duration of the trial. Also, the data obtained has the potential to influence the way CABG surgeries will be performed and utilized in the future.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Conditions

Surgery

Location

The Heart Hospital at Baylor Plano
Plano
Texas
United States
75093

Status

Recruiting

Source

Baylor Research Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:19-0400

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