Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial - Full Text View

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:

MedlinePlus related topics: Heart Surgery

U.S. FDA Resources

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.

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

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

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 May 16, 2013