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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01416792
Recruitment Status : Completed
First Posted : August 15, 2011
Last Update Posted : April 1, 2013
Saskatoon Health Region
Information provided by (Responsible Party):
Erick McNair, 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Heart Valve Diseases Procedure: Centrifugation Procedure: Multiple-pass hemofiltration Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Outcomes & Biochemical Parameters Following Cardiac Surgery: Effects of Transfusion of Residual Blood Using Centrifugation and Multiple-Pass Hemofiltration
Study Start Date : March 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
Experimental: Multiple-pass hemofiltration Procedure: Centrifugation
Other Name: 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 Name: Hemofiltration

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Secondary Outcome Measures :
  1. Allogeneic blood products [ Time Frame: 12-hours post-operatively in ICU ]
    The volume of allogeneic blood products will be recorded.

  2. Ventilation time [ Time Frame: 12-hours post-operatively in ICU ]
    The time between intubation in OR and extubation in the ICU.

  3. Chest tube drainage [ Time Frame: 12-hours post-operatively in ICU ]
    The total volume of chest tube drainage in ICU.

  4. Vasoactive Inotrope score [ Time Frame: 12-hours post-operatively in ICU ]
    We will calculate the vasoactive inotrope score to determine if there is an increased risk of adverse outcomes.

  5. Length of stay in ICU [ Time Frame: Within 24 hours ]
    The average time of discharged from ICU.

  6. Markers of inflammation [ Time Frame: 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).

  7. Indicators of Kidney Function [ Time Frame: 12-hours ICU ]
    Serum creatinine, creatinine clearance, volume of IV fluid intake, volume of urine output, fluid balance

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01416792

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Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
Saskatoon Health Region
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Responsible Party: Erick McNair, Clinical Perfusionist, Adjunct Professor, Department of Surgery, University of Saskatchewan Identifier: NCT01416792    
Other Study ID Numbers: Multiple-pass hemofiltration
First Posted: August 15, 2011    Key Record Dates
Last Update Posted: April 1, 2013
Last Verified: September 2011
Additional relevant MeSH terms:
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Coronary Artery Disease
Heart Valve Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases