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Clinical Trials/NCT01416792
NCT01416792
Completed
N/A

Outcomes & Biochemical Parameters Following Cardiac Surgery: Effects of Transfusion of Residual Blood Using Centrifugation and Multiple-Pass Hemofiltration

University of Saskatchewan1 site in 1 country61 target enrollmentMarch 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
University of Saskatchewan
Enrollment
61
Locations
1
Primary Endpoint
Total Protein
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

Traditional cardiac surgery requires patient connection to the Cardiopulmonary Bypass (CPB) apparatus which takes over the function of the heart and lungs while the surgeon performs the necessary surgery. The residual blood left in the CPB equipment (1.5-2.0 L) is centrifuged and washed leaving only red blood cells (RBCs) suspended in a saline solution. The RBCs are reinfused into the patient as needed by the anesthesiologist. The main problem with this technique is that many of the important components of the blood such as plasma proteins and clotting factors are discarded through cell washing. This study will explore a novel method (multiple-pass hemofiltration) of processing the residual pump blood which will allow the patient to receive their own whole blood with minimum waste of important components. The newer method of processing the residual pump volume has also been termed off-line modified ultrafiltration (off-line MUF) and is similar to the process that the kidneys use to filter the blood. It is hypothesized that multiple-pass hemofiltration of the residual CPB volume will reduce the occurrence of inflammatory responses, preserve plasma proteins, and decrease allogenic blood exposure and improve clinical outcomes as compared to centrifugation.

Detailed Description

This study is being performed because the traditional method of recovery of the residual volume of blood from the cardiopulmonary bypass circuit involves centrifugation and washing of whole blood with a saline solution. This process is sufficient for the recovery of red blood cells however; it results in the discarding of other important components of the blood. The removal of white blood cells, plasma proteins and clotting factors may result in an increased risk of a adverse outcomes during the post-operative period. The new technique our team wants to investigate returns a greater proportion of the patients' whole blood for reinfusion. Our study objectives are to compare the two techniques and determine which technique produces the safest most reliable method of blood processing to help the patient have a smooth, short, transfusion free post-operative period in the intensive care unit (ICU).

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
October 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Erick McNair

Clinical Perfusionist, Adjunct Professor, Department of Surgery

University of Saskatchewan

Eligibility Criteria

Inclusion Criteria

  • all males and females that will be receiving open heart surgery (Coronary Artery Bypass Grafts and / or Valve repair/replacement) during the study period.

Exclusion Criteria

  • history of bleeding disorders
  • history inflammatory diseases rheumatoid arthritis

Outcomes

Primary Outcomes

Total Protein

Time Frame: Baseline, hemodilution, and-12 hours post-operatively in ICU

Serum total protein will be measured in g/L at the specified time intervals.

Hemoglobin

Time Frame: Baseline, Hemodilution and 12-hours post-operatively in ICU

Serum hemoglobin will be measured from the patient at baseline, after hemodilution, and at 12-hours post-operatively in the ICU.

Albumin

Time Frame: baseline, hemodilution and 12-hours post-operatively in ICU

Serum albumin in g/L will be measured at baseline, hemodilution and 12-hours post-operatively in ICU.

Secondary Outcomes

  • Length of stay in ICU(Within 24 hours)
  • Indicators of Kidney Function(12-hours ICU)
  • Allogeneic blood products(12-hours post-operatively in ICU)
  • Ventilation time(12-hours post-operatively in ICU)
  • Chest tube drainage(12-hours post-operatively in ICU)
  • Vasoactive Inotrope score(12-hours post-operatively in ICU)
  • Markers of inflammation(At 12-hours ICU)

Study Sites (1)

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