Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial

NCT01173822 | Completed DMC

• 1 other identifier: PRBC-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiopulmonary Bypass; Hemorrhage; Surgery

Keywords

cardiopulmonary bypass; hemorrhage; trials; surgery

Outcome Measures

Primary Outcomes (1)

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

  At 30 days post-operatively

Secondary Outcomes (5)

• 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

Study Arms (2)

Treatment group

EXPERIMENTAL

Ultra filtration of residual blood.

Other: Ultrafiltration of residual blood

Control

NO INTERVENTION

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

Interventions

Ultrafiltration of residual blood OTHER

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.

Control; Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years of age
• were to undergo isolated on-pump CABG
• were able to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Location

Related Publications (1)

• 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.

  PMID: 23176311 DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Whitlock, MD MSc

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: August 2, 2010
• Study Start: December 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: August 2, 2010

Record last verified: 2010-07

Locations

CA (1)