Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial

Surgery Clinical Trial

— PRBC  

Official title:

Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01173822
• Other study ID #: PRBC-1
• Status: Completed
• Phase: N/A
• First received: July 16, 2010
• Last updated: July 30, 2010
• Start date: December 2004
• Est. completion date: April 2007

Study information

• Verified date: July 2010
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Hemorrhage
• Surgery

Intervention

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.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of patients transfused with homologous red blood cells (RBC)		At 30 days post-operatively	No
Secondary	Proportion of patients transfused with any blood product		At 30 days post-operatively	No
Secondary	Volume of pRBC's transfused post-operative		At 30 days post-operatively	No
Secondary	Post-operative hemorrhage		At 24 hours post-operative	No
Secondary	Discharge Hemoglobin		A date of discharge, median 5 days in study	No
Secondary	Length of hospital stay		From day to surgery to discharge, median 5 days in this study	No