Centrifugation vs. Multiple-pass Hemofiltration of the Residual Cardiopulmonary Bypass Volume

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Heart Valve Diseases
• Interventions: Procedure: Centrifugation; Procedure: Multiple-pass hemofiltration

• Registration Number: NCT01416792
• Lead Sponsor: University of Saskatchewan

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).

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-06-07
• Study First Submitted QC: 2011-08-12
• Study First Posted: 2011-08-15
• Status Verified: 2011-09
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Last Update Submitted: 2013-03-29
• Last Update Posted: 2013-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple-pass hemofiltration	Centrifugation	-
Multiple-pass hemofiltration	Multiple-pass hemofiltration	-

Primary Outcome Measures

Name	Time	Method
Hemoglobin	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	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.
Total Protein	Baseline, hemodilution, and-12 hours post-operatively in ICU	Serum total protein will be measured in g/L at the specified time intervals.

Secondary Outcome Measures

Name	Time	Method
Length of stay in ICU	Within 24 hours	The average time of discharged from ICU.
Indicators of Kidney Function	12-hours ICU	Serum creatinine, creatinine clearance, volume of IV fluid intake, volume of urine output, fluid balance
Allogeneic blood products	12-hours post-operatively in ICU	The volume of allogeneic blood products will be recorded.
Ventilation time	12-hours post-operatively in ICU	The time between intubation in OR and extubation in the ICU.
Chest tube drainage	12-hours post-operatively in ICU	The total volume of chest tube drainage in ICU.
Vasoactive Inotrope score	12-hours post-operatively in ICU	We will calculate the vasoactive inotrope score to determine if there is an increased risk of adverse outcomes.
Markers of inflammation	At 12-hours ICU	Inflammatory mediators: tumor necrosis factor alpha (TNF-alpha), soluble receptors for advanced glycation end products (sRAGE), and high sensitivity C-reactive protein (hs CRP).

Trial Locations

Locations (1)

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada