title: Limit allogeneic blood use with routine re-use of patient's own blood: a prospective, randomized, controlled trial in total hip surgery.
abstract: BACKGROUND
  There are risks related to blood incompatibility and blood-borne diseases when using allogeneic blood transfusion. Several alternatives exist today, one of which, used for autologous blood salvage perioperatively, is the Sangvia Blood Management System. This study was designed to investigate the efficacy of the system and to add data to previously reported safety results.
  
  
  RESULTS
  Two hundred sixteen patients undergoing primary or revision total hip arthroplasty (THA) were enrolled in this randomized, controlled, assessor-blinded multicenter study. Randomization was either autologous blood transfusion (Sangvia group) or no use of autologous blood (Control group), both in combination with a transfusion protocol for allogeneic transfusion. Patients were followed during hospital stay and at two months after discharge. The primary outcome was allogeneic blood transfusion frequency. Data on blood loss, postoperative hemoglobin/hematocrit, safety and quality of life were also collected. The effectiveness analysis including all patients showed an allogeneic blood transfusion rate of 14% in both groups. The efficacy analysis included 197 patients and showed a transfusion rate of 9% in the Sangvia group as compared to 13% in the Control group (95%CI -0.05-0.12, p = 0.5016). A mean of 522 mL autologous blood was returned in the Sangvia group and lower calculated blood loss was seen. 1095 mL vs 1285 mL in the Control group (95%CI 31-346, p = 0.0175). No differences in postoperative hemoglobin was detected but a lower hematocrit reduction after surgery was seen among patients receiving autologous blood. No relevant differences were found for safety parameters or quality of life.
  
  
  CONCLUSIONS
  General low use of allogeneic blood in THA is seen in the current study of the Sangvia system used together with a transfusion protocol. The trial setting is under-powered due to premature termination and therefore not able to verify efficacy for the system itself but contributes with descriptive data on safety.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT00822588.
authors.affiliation: Department of Orthopaedic Surgery, Medical Center Haaglanden, The Hague, The Netherlands. bregje_thomassen@hotmail.com
authors.forename: Bregje J W
authors.initials: BJ
authors.lastname: Thomassen
authors.forename: Peter
authors.initials: P
authors.lastname: Pilot
authors.forename: Vanessa A B
authors.initials: VA
authors.lastname: Scholtes
authors.forename: Josef G
authors.initials: JG
authors.lastname: Grohs
authors.forename: Ketil
authors.initials: K
authors.lastname: Holen
authors.forename: Elvira
authors.initials: E
authors.lastname: Bisbe
authors.forename: Rudolf W
authors.initials: RW
authors.lastname: Poolman
mesh_terms: D000368:Aged; D019644:Arthroplasty, Replacement, Hip; D001803:Blood Transfusion; D001804:Blood Transfusion, Autologous; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged