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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