Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial

Not Applicable

Completed

• Conditions: Cardiopulmonary Bypass; Hemorrhage; Surgery
• Interventions: Other: Ultrafiltration of residual blood

• Registration Number: NCT01173822
• Lead Sponsor: Hamilton Health Sciences Corporation

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.

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2010-07
• Study First Submitted: 2010-07-16
• Study First Submitted QC: 2010-07-30
• Last Update Submitted: 2010-07-30
• Study First Posted: 2010-08-02
• Last Update Posted: 2010-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Ultrafiltration of residual blood	Ultra filtration of residual blood.
Control	Ultrafiltration 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada