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

Primary Purpose

Cardiopulmonary Bypass, Hemorrhage, Surgery

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ultrafiltration of residual blood
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiopulmonary Bypass focused on measuring cardiopulmonary bypass, hemorrhage, trials, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hamilton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment group

Control

Arm Description

Ultra filtration of residual blood.

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.

Outcomes

Primary Outcome Measures

the proportion of patients transfused with homologous red blood cells (RBC)

Secondary Outcome Measures

Proportion of patients transfused with any blood product
Volume of pRBC's transfused post-operative
Post-operative hemorrhage
Discharge Hemoglobin
Length of hospital stay

Full Information

First Posted
July 16, 2010
Last Updated
July 30, 2010
Sponsor
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01173822
Brief Title
Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial
Acronym
PRBC
Official Title
Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Bypass, Hemorrhage, Surgery
Keywords
cardiopulmonary bypass, hemorrhage, trials, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Ultra filtration of residual blood.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Ultrafiltration of residual blood
Intervention Description
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.
Primary Outcome Measure Information:
Title
the proportion of patients transfused with homologous red blood cells (RBC)
Time Frame
At 30 days post-operatively
Secondary Outcome Measure Information:
Title
Proportion of patients transfused with any blood product
Time Frame
At 30 days post-operatively
Title
Volume of pRBC's transfused post-operative
Time Frame
At 30 days post-operatively
Title
Post-operative hemorrhage
Time Frame
At 24 hours post-operative
Title
Discharge Hemoglobin
Time Frame
A date of discharge, median 5 days in study
Title
Length of hospital stay
Time Frame
From day to surgery to discharge, median 5 days in this study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Whitlock, MD MSc
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L2X2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23176311
Citation
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.
Results Reference
derived

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Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial

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