title: The cardiotomy trial: a randomized, double-blind study to assess the effect of processing of shed blood during cardiopulmonary bypass on transfusion and neurocognitive function.
abstract: BACKGROUND
  Reinfusion of unprocessed cardiotomy blood during cardiac surgery can introduce particulate material into the cardiopulmonary bypass circuit, which may contribute to postoperative cognitive dysfunction. On the other hand, processing of this blood by centrifugation and filtration removes coagulation factors and may potentially contribute to coagulopathy. We sought to evaluate the effects of cardiotomy blood processing on blood product use and neurocognitive functioning after cardiac surgery.
  
  
  RESULTS
  Patients undergoing coronary and/or aortic valve surgery using cardiopulmonary bypass were randomized to receive unprocessed blood (control, n=134) or cardiotomy blood that had been processed by centrifugal washing and lipid filtration (treatment, n=132). Patients and treating physicians were blinded to treatment assignment. A strict transfusion protocol was followed. Blood transfusion data were analyzed using Poisson regression models. The treatment group received more intraoperative red blood cell transfusions (0.23+/-0.69 U versus 0.08+/-0.34 U, P=0.004). Both red blood cell and nonred blood cell blood product use was greater in the treatment group and postoperative bleeding was greater in the treatment group. Patients were monitored intraoperatively by transcranial Doppler and they underwent neuropsychometric testing before surgery and at 5 days and 3 months after surgery. There was no difference in the incidence of postoperative cognitive dysfunction in the 2 groups (relative risk: 1.16, 95% CI: 0.86 to 1.57 at 5 days postoperatively; relative risk: 1.05, 95% CI: 0.58 to 1.90 at 3 months). There was no difference in the quality of life nor was there a difference in the number of emboli detected in the 2 groups.
  
  
  CONCLUSIONS
  Contrary to expectations, processing of cardiotomy blood before reinfusion results in greater blood product use with greater postoperative bleeding in patients undergoing cardiac surgery. There is no clinical evidence of any neurologic benefit with this approach in terms of postoperative cognitive function.
authors.affiliation: Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, Ontario, Canada. frubens@ottawaheart.ca
authors.forename: Fraser D
authors.initials: FD
authors.lastname: Rubens
authors.forename: Munir
authors.initials: M
authors.lastname: Boodhwani
authors.forename: Thierry
authors.initials: T
authors.lastname: Mesana
authors.forename: Denise
authors.initials: D
authors.lastname: Wozny
authors.forename: George
authors.initials: G
authors.lastname: Wells
authors.forename: Howard J
authors.initials: HJ
authors.lastname: Nathan
mesh_terms: D000368:Aged; D016063:Blood Loss, Surgical / Q000503:physiopathology*; D001803:Blood Transfusion / Q000379:methods* / Q000523:psychology; D002315:Cardiopulmonary Bypass / Q000379:methods* / Q000523:psychology; D002498:Centrifugation / Q000009:adverse effects; D003071:Cognition / Q000502:physiology*; D003072:Cognition Disorders / Q000517:prevention & control / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D065227:Transfusion Reaction