Cardiopulmonary Bypass, Hemorrhage, Surgery
Conditions
Keywords
cardiopulmonary bypass, hemorrhage, trials, surgery
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.
Interventions
OTHERUltrafiltration of residual blood
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.
Sponsors
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients transfused with homologous red blood cells (RBC) | At 30 days post-operatively |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada
Outcome results
None listed