Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial

Hamilton Health Sciences Corporation200 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Cardiopulmonary Bypass Hemorrhage Surgery

Interventions

Ultrafiltration of residual bloodOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hamilton General Hospital

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

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

Time frame: At 30 days post-operatively

Secondary Outcomes

Proportion of patients transfused with any blood product

Time frame: At 30 days post-operatively

Volume of pRBC's transfused post-operative

Time frame: At 30 days post-operatively

Post-operative hemorrhage

Time frame: At 24 hours post-operative

Discharge Hemoglobin

Time frame: A date of discharge, median 5 days in study

Length of hospital stay

Time frame: From day to surgery to discharge, median 5 days in this study

Data from ClinicalTrials.gov

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