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NCT Number: NCT01173822

Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial

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.

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Key information

Conditions

Cardiopulmonary Bypass Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: At 30 days post-operatively

Secondary outcomes

  1. Proportion of patients transfused with any blood product

    Time frame: At 30 days post-operatively

  2. Volume of pRBC's transfused post-operative

    Time frame: At 30 days post-operatively

  3. Post-operative hemorrhage

    Time frame: At 24 hours post-operative

  4. Discharge Hemoglobin

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

  5. Length of hospital stay

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

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Registry information

Acronym: PRBC

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Aug 2, 2010
Registry last updated
Aug 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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