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

NCT01416792 | Completed

• 1 other identifier: Multiple-pass hemofiltration
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Heart Valve Diseases

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (7)

• Allogeneic blood products

  12-hours post-operatively in ICU

• Ventilation time

  12-hours post-operatively in ICU

• Chest tube drainage

  12-hours post-operatively in ICU

• Vasoactive Inotrope score

  12-hours post-operatively in ICU

• Length of stay in ICU

  Within 24 hours

Study Arms (1)

Multiple-pass hemofiltration

EXPERIMENTAL

Procedure: Centrifugation; Procedure: Multiple-pass hemofiltration

Interventions

Centrifugation PROCEDURE

Also known as: Cell washing

Multiple-pass hemofiltration

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.

Also known as: Hemofiltration

Multiple-pass hemofiltration

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all males and females that will be receiving open heart surgery (Coronary Artery Bypass Grafts and / or Valve repair/replacement) during the study period.

You may not qualify if:

• history of bleeding disorders
• history inflammatory diseases rheumatoid arthritis

Sponsors & Collaborators

• University of Saskatchewan: lead
• Saskatoon Health Region: collaborator

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases

Interventions

Centrifugation; Hemofiltration

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Perfusionist, Adjunct Professor, Department of Surgery

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: August 15, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 1, 2013

Record last verified: 2011-09

Locations

CA (1)