The quality of evidence is downgraded by study limitations (lack of/unclear allocation concealment) and by indirectness of evidence.
A Cochrane review [Abstract] included 8 studies with a total of 1701 patients assessing the effects of tranexamic acid for upper gastrointestinal bleeding.
Tranexamic acid reduced mortality compared to placebo (42 of 851 versus 71 of 850 patients; RR: 0.60, 95% CI 0.42 to 0.87). The analysis was not confirmed when all participants in the intervention group with missing outcome data were included as treatment failures, or when the analysis was limited to trials with low risk of attrition bias. Rebleeding was diagnosed for 117 of 826 participants in the tranexamic acid group and for 146 of 825 participants in the control group (RR 0.80, 95% CI 0.64 to 1.00). Tranexamic acid appeared to reduce the risk of surgery in a fixed-effect meta-analysis (RR 0.73, 95% CI 0.56 to 0.95), but this result was no longer statistically significant in a random-effects meta-analysis (RR 0.61, 95% CI 0.35 to 1.04). No difference was apparent between tranexamic acid and placebo in the assessment of transfusion (RR 1.02, 95% CI 0.94 to 1.11),
| Outcome | Number of patients (studies) | Assumed risk (control) | Corresponding risk (tranexamic acid) | Relative effect RR (95% CI) |
|---|---|---|---|---|
| Mortality (Follow-up: median: 5 days) | 1701 (8) | 84 per 1000 | 50 per 1000 | 0.6 (0.42 to 0.87) |
| Re-bleeding or continuous bleeding | 1651 (7) | 177 per 1000 | 142 per 1000 | 0.72 (0.50 to 1.03) |
| Need for surgery | 1551 (7) | 142 per 1000 | 103 per 1000 | 0.61 (0.35 to 1.04) |
| Transfusion required | 931 (5) | 564 per 1000 | 558 per 1000 | 1.02 (0.94 to 1.10) |
| Any thromboembolic event | 1095 (4) | 11 per 1000 | 20 per 1000 | 1.86 (0.66 to 5.24) |
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