Summary of findings 2. Antifibrinolytic drugs for patients with traumatic brain injury.
Antifibrinolytic drugs compared with placebo for treating patients with traumatic brain injury | ||||||
Patient or population: Treating patients with traumatic brain injury Settings: Hospital settings in Thailand, Colombia and India Intervention: Antifibrinolytic drugs Comparison: Placebo | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
placebo | antifibrinolytic drugs | |||||
Mortality | Study population | RR 0.63 (0.40 to 0.99) | 510 (2 RCTs) | ⊕⊕⊝⊝ LOW 1,2 | ||
163 per 1000 | 103 per 1000 (65 to 162) | |||||
Surgical intervention | Study population | RR 1.12 (0.65 to 1.93) | 510 (2 RCTs) | ⊕⊕⊝⊝ LOW 1,2 | ||
82 per 1000 | 92 per 1000 (53 to 158) | |||||
Progressive intracranial haemorrhage | Study population | RR 0.75 (0.58 to 0.98) | 478 (2 RCTs) | ⊕⊕⊕⊕ HIGH | ||
365 per 1000 | 274 per 1000 (212 to 358) | |||||
New brain lesions | Study population | RR 0.51 (0.20 to 1.32) | 249 (1 RCT) | ⊕⊕⊕⊝ MODERATE 2 | ||
95 per 1000 | 49 per 1000 (19 to 126) | |||||
Myocardial infarction | Study population | RR 0.51 (0.09 to 2.73) | 510 (2 RCTs) | ⊕⊕⊝⊝ LOW 1,2 | ||
12 per 1000 | 6 per 1000 (1 to 32) | |||||
Stroke | Study population | RR 0.34 (0.01 to 8.35) | 510 (2 RCTs) | ⊕⊕⊝⊝ LOW 1,2 | ||
4 per 1000 | 1 per 1000 (0 to 32) | |||||
Deep vein thrombosis | Study population | RR 0.25 (0.03 to 2.26) | 510 (2 RCTs) | ⊕⊕⊝⊝ LOW 1,2 | ||
12 per 1000 | 3 per 1000 (0 to 26) | |||||
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: risk ratio | ||||||
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. |
1Downgraded one level for indirectness: over half (53%) of patients had TBI plus significant extra‐cranial bleeding. Effect may differ in patients with isolated TBI.
2Downgraded one level for imprecision: estimate based on few events and wide CIs that include both an increase and decrease in risk.