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

Tracking Information
First Received Date ^ICMJE	June 7, 2011
Last Updated Date	March 29, 2013
Start Date ^ICMJE	March 2011
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 29, 2013)	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.
Original Primary Outcome Measures ^ICMJE (submitted: August 12, 2011)	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.
Change History	Complete list of historical versions of study NCT01416792 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 29, 2013)	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
Original Secondary Outcome Measures ^ICMJE (submitted: August 12, 2011)	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.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Centrifugation vs. Multiple-pass Hemofiltration of the Residual Cardiopulmonary Bypass Volume
Official Title ^ICMJE	Outcomes & Biochemical Parameters Following Cardiac Surgery: Effects of Transfusion of Residual Blood Using Centrifugation and Multiple-Pass Hemofiltration
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.
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).
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Condition ^ICMJE	Coronary Artery Disease Heart Valve Diseases
Intervention ^ICMJE	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
Study Arm (s)	Experimental: Multiple-pass hemofiltration Interventions: Procedure: Centrifugation Procedure: Multiple-pass hemofiltration
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	61
Completion Date	October 2012
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	40 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT01416792
Other Study ID Numbers ^ICMJE	Multiple-pass hemofiltration
Has Data Monitoring Committee	No
Responsible Party	Erick McNair, University of Saskatchewan
Study Sponsor ^ICMJE	University of Saskatchewan
Collaborators ^ICMJE	Saskatoon Health Region
Investigators ^ICMJE	Not Provided
Information Provided By	University of Saskatchewan
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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