Webert 2008.
Study characteristics | ||
Methods |
Design: RCT, parallel 2‐arm, multicentre feasibility study Setting: 4 tertiary haematology centres (Canada) Recruitment: March 2003 to October 2004 Maximum follow‐up: 30 days |
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Participants | 60 adult participants with acute leukaemia were randomly allocated to 1 of 2 groups:
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Interventions |
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Outcomes | Transfusions, bleeding risk, 30‐day mortality provided by trial authors | |
Notes |
Trial registration: none ascertainable Trial funding: "This study was funded by a grant from Canadian Blood Services and a CIHR Canada Research Chair. KEW was supported by a Canadian Blood Services/Novo Nordisk Research Fellowship in Hemostasis. RJC is a Canada Research Chair" (Webert 2008 p 81) COI statement by investigators: no information provided |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequence generation was computer generated |
Allocation concealment (selection bias) | Low risk | Allocation was Internet based and central |
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' Participants and clinicians were not blinded |
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 (detection bias) Subjective measures | Low risk | No data from subjective outcomes (e.g. function) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No data were missing |
Selective reporting (reporting bias) | Unclear risk | No reporting bias was apparent, but in the absence of prospective registration or a trial protocol, assessment must remain 'unclear' |
Other bias | Low risk | No other biases were apparent |