Table 3 GRADE Approach for RCTs with low risk of bias
Certainty assessment | № of patients | Effect | Certainty | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
№ of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Tranexamic Acid | placebo | Relative (95% CI) | Absolute (95% CI) | |
Mortality | |||||||||||
5 | randomised trials | not serious | not serious | not serious | not serious | none | 2385/15179 (15.7%) | 2575/15083 (17.1%) | RR 0.92 (0.87 to 0.97) | 14 fewer per 1000 (from 22 fewer to 5 fewer) | ⨁⨁⨁⨁ HIGH |
Hemorrhage Expansion | |||||||||||
4 | randomised trials | not serious | not serious | not serious | not serious | none | 106/471 (22.5%) | 135/467 (28.9%) | RR 0.78 (0.63 to 0.97) | 64 fewer per 1000 from 107 fewer to 9 fewer) | ⨁⨁⨁⨁ HIGH |
Need for Neurosurgical Intervention | |||||||||||
4 | randomised trials | not serious | not serious | not serious | not serious | none | 1113/10566 (10.5%) | 1125/10569 (10.6%) | RR 0.99 (0.89 to 1.12) | 1 fewer per 1000 (from 12 fewer to 13 more) | ⨁⨁⨁⨁ HIGH |
Unfavourable GOS | |||||||||||
3 | randomised trials | not serious | not serious | not serious | serious a | none | 137/455 (30.1%) | 147/463 (31.7%) | RR 0.93 (0.72 to 1.21) | 22 fewer per 1000 (from 89 fewer to 67 more) | ⨁⨁⨁◯ MODERATE |
Vascular Occlusive Events | |||||||||||
4 | randomised trials | not serious | serious b | not serious | not serious | none | 328/67281 (0.5%) | 387/66981 (0.6%) | RR 0.85 (0.73 to 0.99) | 1 fewer per 1000 (from 2 fewer to 0 fewer) | ⨁⨁⨁◯ MODERATE |
Vascular Occlusive Events - DVT | |||||||||||
4 | randomised trials | not serious | not serious | not serious | serious a | none | 67/16851 (0.4%) | 82/16774 (0.5%) | RR 0.79(0.53 to 1.19) | 1 fewer per 1000 (from 2 fewer to 1 more) | ⨁⨁⨁◯ MODERATE |
Vascular Occlusive Events - MI | |||||||||||
3 | randomised trials | not serious | not serious | not serious | serious a | none | 56/16731 (0.3%) | 76/16656 (0.5%) | RR 0.75 (0.50 to 1.11) | 1 fewer per 1000 (from 2 fewer to 1 more) | ⨁⨁⨁◯ MODERATE |