Background
Methods
Study criteria
Systematic search
Trial selection and data extraction
Quality assessment
Outcomes
Statistical analysis
Results
Literature search
Description of included studies
No. of trials n = 234 | No. of participants n = 102,681 | |
---|---|---|
Trial characteristics | ||
Multicenter study | 26 | 80,268 |
Single-center study | 208 | 22,413 |
Patient disease type | ||
Trauma (including traumatic brain injury) | 7 | 34,488 |
Obstetrics and gynecology | 22 | 28,089 |
Cardiac surgery | 47 | 10,528 |
Orthopedic surgery | 124 | 11,353 |
Intracranial (non-traumatic) hemorrhage | 9 | 4057 |
Gastrointestinal hemorrhage | 3 | 12,312 |
Others | 22 | 1854 |
Patient characteristics | ||
Mean age (year) of trial arms, median [IQR] | Control: 54 [43–66] Intervention: 50 [46–67] | |
Percentage of female patients in trial arms, median [IQR] | Control: 54 [35–70] Intervention: 53 [31–73] | |
Adults | 225 | 101,917 |
Pediatrics | 9 | 764 |
TXA dose | ||
≦ 2 g/day | 180 | 78,268 |
2 g/day < TXA dose ≦ 4 g/day | 14 | 13,887 |
> 4 g | 20 | 7603 |
Composite | 20 | 2923 |
TXA regimen | ||
Bolus administration | 149 | 47,973 |
Continuous infusion | 4 | 785 |
Bolus + infusion | 80 | 53,848 |
Risk of bias in individual trials
Primary outcome in all hemorrhagic patients
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 |