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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01416792
• Other study ID #: Multiple-pass hemofiltration
• Status: Completed
• Phase: N/A
• First received: June 7, 2011
• Last updated: March 29, 2013
• Start date: March 2011
• Est. completion date: October 2012

Study information

• Verified date: September 2011
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Valve Diseases
• Myocardial Ischemia

Intervention

Procedure:
• Centrifugation

• 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.

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Saskatoon Health Region

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Allogeneic blood products	The volume of allogeneic blood products will be recorded.	12-hours post-operatively in ICU	No
Secondary	Ventilation time	The time between intubation in OR and extubation in the ICU.	12-hours post-operatively in ICU	No
Secondary	Chest tube drainage	The total volume of chest tube drainage in ICU.	12-hours post-operatively in ICU	No
Secondary	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	No
Secondary	Length of stay in ICU	The average time of discharged from ICU.	Within 24 hours	No
Secondary	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	No
Secondary	Indicators of Kidney Function	Serum creatinine, creatinine clearance, volume of IV fluid intake, volume of urine output, fluid balance	12-hours ICU	No