Centrifugation vs. Multiple-pass Hemofiltration of the Residual Cardiopulmonary Bypass Volume
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.
Coronary Artery Disease
Heart Valve Diseases
Procedure: Multiple-pass hemofiltration
|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|
- 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.
- 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
|Study Start Date:||March 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
|Experimental: Multiple-pass hemofiltration||
Other Name: Cell washingProcedure: 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
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416792
|Royal University Hospital|
|Saskatoon, Saskatchewan, Canada, S7N 0W8|