Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial

This study has been completed.
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT01173822
First received: July 16, 2010
Last updated: July 30, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Cardiopulmonary Bypass
Hemorrhage
Surgery
Other: Ultrafiltration of residual blood

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • the proportion of patients transfused with homologous red blood cells (RBC) [ Time Frame: At 30 days post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients transfused with any blood product [ Time Frame: At 30 days post-operatively ] [ Designated as safety issue: No ]
  • Volume of pRBC's transfused post-operative [ Time Frame: At 30 days post-operatively ] [ Designated as safety issue: No ]
  • Post-operative hemorrhage [ Time Frame: At 24 hours post-operative ] [ Designated as safety issue: No ]
  • Discharge Hemoglobin [ Time Frame: A date of discharge, median 5 days in study ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: From day to surgery to discharge, median 5 days in this study ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: December 2004
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173822

Locations
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L2X2
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Richard Whitlock, MD MSc Hamilton Health Sciences Corporation
  More Information

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Richard Whitlock, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT01173822     History of Changes
Other Study ID Numbers: PRBC-1
Study First Received: July 16, 2010
Last Updated: July 30, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
cardiopulmonary bypass
hemorrhage
trials
surgery

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014