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

This study has been completed.
Sponsor:
Collaborator:
Saskatoon Health Region
Information provided by (Responsible Party):
Erick McNair, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01416792
First received: June 7, 2011
Last updated: March 29, 2013
Last verified: September 2011
History of Changes
  Purpose

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 Intervention
Coronary Artery Disease
Heart Valve Diseases
 Procedure: Centrifugation
Procedure: Multiple-pass hemofiltration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Outcomes & Biochemical Parameters Following Cardiac Surgery: Effects of Transfusion of Residual Blood Using Centrifugation and Multiple-Pass Hemofiltration

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Hemoglobin [ Time Frame: Baseline, Hemodilution and 12-hours post-operatively in ICU ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Serum albumin in g/L will be measured at baseline, hemodilution and 12-hours post-operatively in ICU.

  • Total Protein [ Time Frame: Baseline, hemodilution, and-12 hours post-operatively in ICU ] [ Designated as safety issue: No ]
    Serum total protein will be measured in g/L at the specified time intervals.


Secondary Outcome Measures:
  • Allogeneic blood products [ Time Frame: 12-hours post-operatively in ICU ] [ Designated as safety issue: No ]
    The volume of allogeneic blood products will be recorded.

  • Ventilation time [ Time Frame: 12-hours post-operatively in ICU ] [ Designated as safety issue: No ]
    The time between intubation in OR and extubation in the ICU.

  • Chest tube drainage [ Time Frame: 12-hours post-operatively in ICU ] [ Designated as safety issue: No ]
    The total volume of chest tube drainage in ICU.

  • Vasoactive Inotrope score [ Time Frame: 12-hours post-operatively in ICU ] [ Designated as safety issue: No ]
    We will calculate the vasoactive inotrope score to determine if there is an increased risk of adverse outcomes.

  • Length of stay in ICU [ Time Frame: Within 24 hours ] [ Designated as safety issue: No ]
    The average time of discharged from ICU.

  • Markers of inflammation [ Time Frame: At 12-hours ICU ] [ Designated as safety issue: No ]
    Inflammatory mediators: tumor necrosis factor alpha (TNF-alpha), soluble receptors for advanced glycation end products (sRAGE), and high sensitivity C-reactive protein (hs CRP).

  • Indicators of Kidney Function [ Time Frame: 12-hours ICU ] [ Designated as safety issue: No ]
    Serum creatinine, creatinine clearance, volume of IV fluid intake, volume of urine output, fluid balance


Enrollment: 61
Study Start Date: March 2011
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416792

Locations
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
Saskatoon Health Region
  More Information

No publications provided

Responsible Party: Erick McNair, Clinical Perfusionist, Adjunct Professor, Department of Surgery, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01416792     History of Changes
Other Study ID Numbers: Multiple-pass hemofiltration
Study First Received: June 7, 2011
Last Updated: March 29, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Valve Diseases
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013