Barer 1983.
Methods | Randomised trial on tranexamic acid vs cimetidine vs placebo | |
Participants | Inclusion criteria: patients admitted with upper gastrointestinal bleeding confirmed by observation of haematemesis or melena
Number of participants randomly assigned: 516 Mean age: 60‐63 years Proportion:
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Interventions | Tranexamic acid 1 g IV 4 times/d then 1 g orally 4 times/d vs cimetidine 400 mg IV 4 times/d then 400 mg orally 4 times/d vs placebo | |
Outcomes | All‐cause mortality, rebleeding, surgery and adverse events | |
Endoscopy | Performed within 24 hours of admission | |
Definition of re‐bleeding | Severe hematemesis or fresh melena or a fall in haemoglobin of at least 2 g/dL within 24 hours after the first day of admission | |
Duration of therapy | 7 days | |
Notes | Kabi Vitrum Ltd and Smith Kline and French supplied medications; details of funding not supplied | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Allocation sequence based on random numbers |
Allocation concealment (selection bias) | Low risk | Central packaging of coded drug containers |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double blinding (using placebo) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and personnel blinded (using placebo) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcomes assessed in a blinded manner (using placebo) |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | In total, 99 participants were excluded after randomisation. Reporting of follow‐up and handling of missing outcome data are clear |
Selective reporting (reporting bias) | Low risk | Mortality and bleeding are reported |
Other bias | Low risk | No other apparent biases are reported |