Limit allogeneic blood use with routine re-use of patient's own blood: a prospective, randomized, controlled trial in total hip surgery

Bregje J W Thomassen, Peter Pilot, Vanessa A B Scholtes, Josef G Grohs, Ketil Holen, Elvira Bisbe, Rudolf W Poolman, Bregje J W Thomassen, Peter Pilot, Vanessa A B Scholtes, Josef G Grohs, Ketil Holen, Elvira Bisbe, Rudolf W Poolman

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.

Methodology/principal findings: 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/significance: 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.

Trial registration: Clinicaltrials.gov NCT00822588.

Conflict of interest statement

Competing Interests: The authors have received funding by Astra Tech AB, Mölndal, Sweden, but this does not alter the authors' adherence to all the PLoS ONE policies on sharing data and materials.

Figures

Figure 1. Study patient flow and definition…
Figure 1. Study patient flow and definition of analysis sets.

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