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

Primary Purpose

Coronary Artery Disease, Heart Valve Diseases

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Centrifugation
Multiple-pass hemofiltration
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multiple-pass hemofiltration

Arm Description

Outcomes

Primary Outcome Measures

Hemoglobin
Serum hemoglobin will be measured from the patient at baseline, after hemodilution, and at 12-hours post-operatively in the ICU.
Albumin
Serum albumin in g/L will be measured at baseline, hemodilution and 12-hours post-operatively in ICU.
Total Protein
Serum total protein will be measured in g/L at the specified time intervals.

Secondary Outcome Measures

Allogeneic blood products
The volume of allogeneic blood products will be recorded.
Ventilation time
The time between intubation in OR and extubation in the ICU.
Chest tube drainage
The total volume of chest tube drainage in ICU.
Vasoactive Inotrope score
We will calculate the vasoactive inotrope score to determine if there is an increased risk of adverse outcomes.
Length of stay in ICU
The average time of discharged from ICU.
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).
Indicators of Kidney Function
Serum creatinine, creatinine clearance, volume of IV fluid intake, volume of urine output, fluid balance

Full Information

First Posted
June 7, 2011
Last Updated
March 29, 2013
Sponsor
University of Saskatchewan
Collaborators
Saskatoon Health Region
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1. Study Identification

Unique Protocol Identification Number
NCT01416792
Brief Title
Centrifugation vs. Multiple-pass Hemofiltration of the Residual Cardiopulmonary Bypass Volume
Official Title
Outcomes & Biochemical Parameters Following Cardiac Surgery: Effects of Transfusion of Residual Blood Using Centrifugation and Multiple-Pass Hemofiltration
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
Saskatoon Health Region

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Heart Valve Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multiple-pass hemofiltration
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Centrifugation
Other Intervention Name(s)
Cell washing
Intervention Type
Procedure
Intervention Name(s)
Multiple-pass hemofiltration
Other Intervention Name(s)
Hemofiltration
Intervention Description
The residual volume from the CPB circuit is pumped though a hemofilter for multiple passes removing the crystalloid component thereby concentrating the plasma.
Primary Outcome Measure Information:
Title
Hemoglobin
Description
Serum hemoglobin will be measured from the patient at baseline, after hemodilution, and at 12-hours post-operatively in the ICU.
Time Frame
Baseline, Hemodilution and 12-hours post-operatively in ICU
Title
Albumin
Description
Serum albumin in g/L will be measured at baseline, hemodilution and 12-hours post-operatively in ICU.
Time Frame
baseline, hemodilution and 12-hours post-operatively in ICU
Title
Total Protein
Description
Serum total protein will be measured in g/L at the specified time intervals.
Time Frame
Baseline, hemodilution, and-12 hours post-operatively in ICU
Secondary Outcome Measure Information:
Title
Allogeneic blood products
Description
The volume of allogeneic blood products will be recorded.
Time Frame
12-hours post-operatively in ICU
Title
Ventilation time
Description
The time between intubation in OR and extubation in the ICU.
Time Frame
12-hours post-operatively in ICU
Title
Chest tube drainage
Description
The total volume of chest tube drainage in ICU.
Time Frame
12-hours post-operatively in ICU
Title
Vasoactive Inotrope score
Description
We will calculate the vasoactive inotrope score to determine if there is an increased risk of adverse outcomes.
Time Frame
12-hours post-operatively in ICU
Title
Length of stay in ICU
Description
The average time of discharged from ICU.
Time Frame
Within 24 hours
Title
Markers of inflammation
Description
Inflammatory mediators: tumor necrosis factor alpha (TNF-alpha), soluble receptors for advanced glycation end products (sRAGE), and high sensitivity C-reactive protein (hs CRP).
Time Frame
At 12-hours ICU
Title
Indicators of Kidney Function
Description
Serum creatinine, creatinine clearance, volume of IV fluid intake, volume of urine output, fluid balance
Time Frame
12-hours ICU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada

12. IPD Sharing Statement

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

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