Jairath 2015.
Methods | Cluster‐randomised trial pilot study involving 6 hospitals | |
Participants | Participants were 18 years of age or older and admitted to 1 of the participating hospitals with upper gastrointestinal bleeding. Participants with exsanguinating haemorrhage were excluded. Participants consented to permit data collection and follow‐up. |
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Interventions | The following transfusion strategy was encouraged at each participating hospital:
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Outcomes | Feasibility outcomes included recruitment rates, adherence to transfusion policy, difference in haemoglobin concentration, RBC exposure, and evidence for selection bias. Clinical outcomes included further bleeding, thromboembolic and ischaemic events, number of infections, mortality, serious adverse events, and health‐related quality of life. | |
Notes | This was the only cluster trial in our review. It did not require participants to meet a haemoglobin threshold for enrolment. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The hospital was randomized, not the individual participant. |
Allocation concealment (selection bias) | High risk | The hospital was randomized, so everyone knew which arm the participants were in. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The trial was not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Mortality allowed a judgement of low risk of bias. Assessment of other clinical outcomes was unblinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | There was a high percentage of missing data. |
Selective reporting (reporting bias) | Unclear risk | No reporting bias was apparent. |
Other bias | High risk | There was differential enrolment by treatment arms. |