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

June 7, 2011
March 29, 2013
March 2011
September 2012   (final data collection date for primary outcome measure)
  • 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.
  • CBC (Complete Blood Count) [ Time Frame: 12 hours post-operatively in ICU ] [ Designated as safety issue: No ]
    CBC will be measured from the residual pump volume before centrifugation (method 1) or before hemofiltration (method 2) and 12 hours postoperatively in the ICU.
  • Serum Creatinine [ Time Frame: 12 hours postoperatively in ICU ] [ Designated as safety issue: No ]
    Serum creatinine will be measured 12 hours postoperatively in ICU.
  • Inflammatory response [ Time Frame: 12 hours post-operatively in ICU ] [ Designated as safety issue: No ]
    C-reative protein, TNF-alpha, and sRAGE will be measured 12 hours postoperatively in ICU.
Complete list of historical versions of study NCT01416792 on ClinicalTrials.gov Archive Site
  • 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
  • Use of allogenic blood products [ Time Frame: within 12 hours postoperatively in ICU ] [ Designated as safety issue: No ]
    The usage of allogenic blood products will be recorded.
  • Ventilation time [ Time Frame: Within 12 hours postoperatively in ICU ] [ Designated as safety issue: No ]
    We will measure the time between intubation and extubation in the ICU.
  • Chest tube drainage [ Time Frame: Within 12 hours postoperatively in ICU ] [ Designated as safety issue: No ]
    We will measure the total chest tube drainage in ICU.
  • Blood pressure [ Time Frame: Within 12 hours postoperatively in ICU ] [ Designated as safety issue: No ]
    We will measure the average mean arterial pressure during the 12 hour postoperative period.
  • Length of stay in ICU [ Time Frame: Within 48 hours ] [ Designated as safety issue: No ]
    The average patient is discharged from ICU within 48 hours.
Not Provided
Not Provided
 
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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Heart Valve Diseases
  • 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
Experimental: Multiple-pass hemofiltration
Interventions:
  • Procedure: Centrifugation
  • Procedure: Multiple-pass hemofiltration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
October 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01416792
Multiple-pass hemofiltration
No
Erick McNair, University of Saskatchewan
University of Saskatchewan
Saskatoon Health Region
Not Provided
University of Saskatchewan
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP