Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial

Hamilton Health Sciences (HHS)

Status: Completed

Conditions: Hemorrhage; Surgery; Cardiopulmonary Bypass

Treatments: Other: Ultrafiltration of residual blood

Study type: Interventional

Funder types: Other

Identifiers

NCT01173822

PRBC-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Treatment group

Experimental group

Description:

Ultra filtration of residual blood.

Treatment:

Other: Ultrafiltration of residual blood

Control

No Intervention group

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.

Treatment:

Other: Ultrafiltration of residual blood