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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Heart Valve Diseases
• Intervention / Treatment: Procedure: Centrifugation; Procedure: Multiple-pass hemofiltration

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multiple-pass hemofiltration	Procedure: Centrifugation; Other Names: Cell washing; Procedure: Multiple-pass hemofiltration; The residual volume from the CPB circuit is pumped though a hemofilter for multiple passes removing the crystalloid component thereby concentrating the plasma.; Other Names: Hemofiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin	Serum hemoglobin will be measured from the patient at baseline, after hemodilution, and at 12-hours post-operatively in the ICU.	Baseline, Hemodilution and 12-hours post-operatively in ICU
Albumin	Serum albumin in g/L will be measured at baseline, hemodilution and 12-hours post-operatively in ICU.	baseline, hemodilution and 12-hours post-operatively in ICU
Total Protein	Serum total protein will be measured in g/L at the specified time intervals.	Baseline, hemodilution, and-12 hours post-operatively in ICU

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Collaborators: Saskatoon Health Region

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: June 7, 2011
• First Submitted That Met QC Criteria: August 12, 2011
• First Posted (Estimate): August 15, 2011

Study Record Updates

• Last Update Posted (Estimate): April 1, 2013
• Last Update Submitted That Met QC Criteria: March 29, 2013
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Heart Valve Diseases
• Other Study ID Numbers: Multiple-pass hemofiltration