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Table 2 GRADE evidence profile: TXA for bleeding patients

From: Effect of tranexamic acid on thrombotic events and seizures in bleeding patients: a systematic review and meta-analysis

Certainty assessment No. of patients Effect Certainty Importance
No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations TXA Control Relative
(95% CI)
Absolute
(95% CI)
Thrombotic events
230 Randomized trials Not serious Not serious Not serious Not
serious
None 1342/52103 (2.5%) 1278/50211 (2.5%) RR 1.00
(0.93 to 1.08)
0 fewer per 1000
(from 2 fewer to 2 more)

HIGH
CRITICAL
Seizures
40 Randomized trials Not serious Not seriousb Not serious Seriousa None 404/30351 (1.3%) 351/29847
(1.1%)
RR 1.18
(0.91 to 1.53)
2 more per 1000
(from 1 fewer to 6 more)

MODERATE
CRITICAL
Seizures (dose > 2 g/day)
7 Randomized trials Not serious Not serious Not serious Not
serious
None 55/8642 (0.6%) 24/8666 (0.3%) RR 3.05
(1.01 to 9.20)
6 more per 1000
(from 0 fewer to 23 more)

HIGH
CRITICAL
Seizures (dose ≤ 2 g/day)
33 Randomized
trials
Not
serious
Not
serious
Not
serious
Not
serious
None 349/21709
(1.6%)
327/21181
(1.5%)
RR 1.02
(0.88 to 1.19)
0 more per 1000
(from 2 fewer to 3 more)

HIGH
CRITICAL
  1. a. Confidence interval includes effects suggesting benefit as well as no effect (downgraded by 1 level for imprecision)
  2. b. Although there observed no inconsistency (I2 = 34%), clinical heterogeneity was suspected and further analysis was performed according to TXA dose
  3. GRADE, grading of recommendations, assessment, development and evaluation. TXA, tranexamic acid. RR, risk ratio. CI, confidence interval