Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial (PRBC)

The study is an randomized controlled trial (RCT) of 198 coronary artery bypass graft (CABG) patients, exploring whether ultrafiltration of residual blood in the cardiopulmonary bypass circuit reduces transfusion and bleeding.

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Surgery; Cardiopulmonary Bypass
• Intervention / Treatment: Other: Ultrafiltration of residual blood

Detailed Description

Blood products are a limited resource and cardiac surgery is a high consumer. Processing residual cardiopulmonary bypass (CPB) volume via ultrafiltration may improve hemostasis and reduce transfusion through clearing activated complement, activated coagulation components, and proinflammatory cytokines. Unlike cell saver technology, ultrafiltration has the advantage of maintaining plasma proteins, platelets, and coagulation factors. We sought to establish if the processing of residual CPB volume with ultrafiltration reduces homologous blood transfusion and bleeding.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L2X2
      • Hamilton General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• at least 18 years of age
• were to undergo isolated on-pump CABG
• were able to give informed consent

Exclusion Criteria:

• performed autologous blood donation
• underwent off-pump CABG
• emergency procedure
• resternotomy
• known bleeding disorder not drug related
• history of heparin-induced thrombocytopenia
• Jehovah's Witness
• intra-operative catastrophe prior to randomization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Ultra filtration of residual blood.	Other: Ultrafiltration of residual blood; The inflow line to the hemoconcentrator was connected to the sideport of the arterial filter stopcock, allowing the residual blood in the CPB circuit to be processed through the hemoconcentrator. The outflow line from the hemoconcentrator was connected to a second three way stopcock located on the cardiotomy reservoir. Blood was circulated from the venous reservoir through the hemoconcentrator and returned to the venous reservoir until the desired hematocrit was achieved. The blood was then diverted to a transfer pack until all the blood from the venous reservoir, heat exchanger, and membrane oxygenator had been filtered and hemoconcentrated. This transfer pack was given to the anesthetist for reinfusion into the patient.
No Intervention: Control; The current practice in our institution was to displace all the remaining volume in the CPB circuit into a transfer pack by displacing the remaining blood in the CPB circuit with additional Lactated Ringers solution. This transfer pack is then given to the anesthetist for reinfusion into the patient.	Other: Ultrafiltration of residual blood; The inflow line to the hemoconcentrator was connected to the sideport of the arterial filter stopcock, allowing the residual blood in the CPB circuit to be processed through the hemoconcentrator. The outflow line from the hemoconcentrator was connected to a second three way stopcock located on the cardiotomy reservoir. Blood was circulated from the venous reservoir through the hemoconcentrator and returned to the venous reservoir until the desired hematocrit was achieved. The blood was then diverted to a transfer pack until all the blood from the venous reservoir, heat exchanger, and membrane oxygenator had been filtered and hemoconcentrated. This transfer pack was given to the anesthetist for reinfusion into the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the proportion of patients transfused with homologous red blood cells (RBC)	At 30 days post-operatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients transfused with any blood product	At 30 days post-operatively
Volume of pRBC's transfused post-operative	At 30 days post-operatively
Post-operative hemorrhage	At 24 hours post-operative
Discharge Hemoglobin	A date of discharge, median 5 days in study
Length of hospital stay	From day to surgery to discharge, median 5 days in this study

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: Richard Whitlock, MD MSc, Hamilton Health Sciences Corporation

Publications and helpful links

General Publications

• Whitlock R, Mathew J, Eikelboom J, Al-Saleh AM, Yuan F, Teoh K. Processed residual pump blood in cardiac surgery: the Processed Residual Blood in Cardiac surgery trial. Transfusion. 2013 Jul;53(7):1487-92. doi: 10.1111/j.1537-2995.2012.03958.x. Epub 2012 Nov 26.

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): April 1, 2007
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: July 16, 2010
• First Submitted That Met QC Criteria: July 30, 2010
• First Posted (Estimate): August 2, 2010

Study Record Updates

• Last Update Posted (Estimate): August 2, 2010
• Last Update Submitted That Met QC Criteria: July 30, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: surgery; hemorrhage; cardiopulmonary bypass; trials
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: PRBC-1