Palmieri 2017.
Study characteristics | ||
Methods |
Design: RCT, parallel 2‐arm, phase 3, multicentre, international trial Setting: 18 burn centres located in 3 countries (USA (16), Canada (1), New Zealand (1)) Recruitment: August 2010 to August 2015 Maximum follow‐up: mortality reported at and after 30 days; 'after' not specified |
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Participants | 345 participants 19 years of age or older admitted to burn unit within 96 hours of injury with a burn of 20% or more; need for burn excision and grafting was anticipated
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Interventions |
Transfusion was administered 1 unit at a time |
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Outcomes |
Primary outcome: bloodstream infection Secondary outcomes included: mortality, number of infectious episodes (urinary tract infections, pneumonia, wound infection), burn ICU length of stay, hospital length of stay, duration of mechanical ventilation, organ dysfunction (MODS), time to 90% burn wound healing (defined as 7 days after last excision and grafting procedure) |
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Notes |
Trial registration (prospective): NCT01079247 Trial funding: "this study was supported by the American Burn Association and funded by USAMRMC Award W81XWH‐08‐1‐0760 with support from the National Center for Research Resources, National Institutes of Health, through grant UL1 RR024146, the National Center for Advancing Translational Sciences, National Institutes of Health, through grant TR 000002, and the National Center for Advancing Translational Sciences, National Institutes of Health through grant UL1 TR001860" (Palmieri 2017 p 1) COI statement by investigators: "Dr. Holmes: equity positions in Abbott Labs, AbbVie, and Permeaderm Inc. Dr. Tredget: contract research, Scar X, KLOX Therapeutics, and Exciton (ExSALT), collaborative research British Canadian BioSciences Corp (novel antifibrotic agent). The remaining authors report no conflicts of interest" (Palmieri 2017 p 1) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Not specified but adaptive random allocation procedure used to balance groups with respect to screening prognostic variables using a "biased coin" procedure, which creates low risk of bias |
Allocation concealment (selection bias) | Low risk | Not specified but adaptive random allocation procedure used to balance groups with respect to screening prognostic variables using a "biased coin" procedure, which creates low risk of bias |
Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Blinding of personnel for this intervention is not feasible, but in our view, for objective outcomes such as mortality (the primary outcome used within this review), we graded risk of bias as 'low' Blinding of participants and personnel was not addressed |
Blinding of outcome assessment (detection bias) Objective measures | Low risk | Blinding of mortality (the primary outcome used within this review) is not relevant, and we graded risk of bias as 'low' Blinding of outcome assessment was not addressed |
Blinding of outcome assessment (detection bias) Subjective measures | Low risk | No data from subjective outcomes (e.g. function) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 29 (8%) patients withdrew |
Selective reporting (reporting bias) | Low risk | Trial was prospectively registered (NCT01079247). No reporting bias was apparent |
Other bias | Low risk | No other biases were apparent |