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NCT Number: NCT01416792

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Centrifugation

Procedure

Other names: Cell washing

Multiple-pass hemofiltration

Procedure

The residual volume from the CPB circuit is pumped though a hemofilter for multiple passes removing the crystalloid component thereby concentrating the plasma.

Other names: Hemofiltration

Primary outcomes

  1. Hemoglobin

    Time frame: Baseline, Hemodilution and 12-hours post-operatively in ICU

    Serum hemoglobin will be measured from the patient at baseline, after hemodilution, and at 12-hours post-operatively in the ICU.

  2. Albumin

    Time frame: baseline, hemodilution and 12-hours post-operatively in ICU

    Serum albumin in g/L will be measured at baseline, hemodilution and 12-hours post-operatively in ICU.

  3. Total Protein

    Time frame: Baseline, hemodilution, and-12 hours post-operatively in ICU

    Serum total protein will be measured in g/L at the specified time intervals.

Secondary outcomes

  1. Allogeneic blood products

    Time frame: 12-hours post-operatively in ICU

    The volume of allogeneic blood products will be recorded.

  2. Ventilation time

    Time frame: 12-hours post-operatively in ICU

    The time between intubation in OR and extubation in the ICU.

  3. Chest tube drainage

    Time frame: 12-hours post-operatively in ICU

    The total volume of chest tube drainage in ICU.

  4. Vasoactive Inotrope score

    Time frame: 12-hours post-operatively in ICU

    We will calculate the vasoactive inotrope score to determine if there is an increased risk of adverse outcomes.

  5. Length of stay in ICU

    Time frame: Within 24 hours

    The average time of discharged from ICU.

  6. Markers of inflammation

    Time frame: At 12-hours ICU

    Inflammatory mediators: tumor necrosis factor alpha (TNF-alpha), soluble receptors for advanced glycation end products (sRAGE), and high sensitivity C-reactive protein (hs CRP).

  7. Indicators of Kidney Function

    Time frame: 12-hours ICU

    Serum creatinine, creatinine clearance, volume of IV fluid intake, volume of urine output, fluid balance

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Saskatoon Health Region

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 15, 2011
Registry last updated
Apr 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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