Trial reportPloS one2012
Limit allogeneic blood use with routine re-use of patient's own blood: a prospective, randomized, controlled trial in total hip surgery.
Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00822588 (A Prospective, Randomized, Controlled Trial of Retransfusion of Intra-operatively Collected Filtered Whole Blood in Total Hip Surgery), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective, Randomized, Controlled Trial of Retransfusion of Intra-operatively Collected Filtered Whole Blood in Total Hip Surgery
Who cites it
7 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Cell salvage for minimising perioperative allogeneic blood transfusion in adults undergoing elective surgery.The Cochrane database of systematic reviews · 2023Pooled it
- Postoperative autotransfusion drain after total hip arthroplasty: a meta-analysis of randomized controlled trials.Scientific reports · 2016Pooled it
- Dynamic changes in clot formation determined using thromboelastometry after reinfusion of unwashed anticoagulated cell-salvaged whole blood in total hip arthroplasty.Blood transfusion = Trasfusione del sangue · 2015Trial
- De-implementation of expensive blood saving measures in hip and knee arthroplasties: study protocol for the LISBOA-II cluster randomized trial.Implementation science : IS · 2014Trial
- Short-term mortality after primary and revision total joint arthroplasty: a single-center analysis of 103,560 patients.Archives of orthopaedic and trauma surgery · 2021Article
- Operative Time Directly Correlates with Blood Loss and Need for Blood Transfusion in Total Joint Arthroplasty.The archives of bone and joint surgery · 2019Article
- Blood management and transfusion strategies in 600 patients undergoing total joint arthroplasty: an analysis of pre-operative autologous blood donation.Blood transfusion = Trasfusione del sangue · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere 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
findingsTwo 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 registrationClinicaltrials.gov NCT00822588.
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