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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01416792
Other study ID # Multiple-pass hemofiltration
Secondary ID
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


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
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