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. 2021 Dec 21;2021(12):CD002042. doi: 10.1002/14651858.CD002042.pub5

Robitaille 2013.

Study characteristics
Methods Design: RCT, intended to be multicentre trial 
Setting: 1 institution (not identified), Canada
Recruitment: June 2009
Maximum follow‐up: intended to be 5 years (overall survival)
Participants Children aged 1 to 18 years who were undergoing an allogeneic BMT for malignant or benign disease (except sickle cell disease) were eligible
Recruitment target was 62; enrolment was 6
3 ‐ liberal threshold trigger transfusion strategy 
3 ‐ restrictive threshold trigger transfusion strategy
Interventions
  • Liberal group: transfusion administered at threshold of 12.0 g/dL

  • Restrictive group: transfusion administered at threshold of 7.0 g/dL

Outcomes Time to neutrophil engraftment, time to platelet engraftment, transfusions given, length of stay, immune reconstitution, mortality/overall survival (2 to 5 years), graft vs host disease, relapse, chimerism
Notes Trial closed early due to an excess of cases of veno‐occlusive disease in 3 out of 6 cases, all in the intervention (liberal) arm
Trial registration: NCT00937053
Trial funding: Fonds de laRecherche en Santé du Québec (grants 9967 and 24460)
COI statement by investigators: "the authors declare no conflict of interest to report"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Randomization of patients was done on the first day of their conditioning regimen using a web‐based randomization system" (Robitaille 2013 p 469)
Allocation concealment (selection bias) Low risk As above ‐ no further information supplied
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 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'
Primary outcome of veno‐occlusive diease is also a hard outcome
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 All data presented for small cohort
Selective reporting (reporting bias) Low risk All data presented for small cohort; 1 death at 6 months in experimental arm. Small sample size rendered many predefined outcomes inappropriate
Other bias Low risk Trial closed early due to an excess of cases of veno‐occlusive disease in 3 out of 6 cases, all in the intervention (liberal) arm
Overall considered at low risk of bias based on limited data available for analysis within this review