Skip to main content
. 2014 Nov 21;2014(11):CD006640. doi: 10.1002/14651858.CD006640.pub3

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:
  • of men: 65%

  • with peptic ulcer: 58%

  • with oesophageal varices: 5%

  • with massive bleeding: 13%

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