Table 3.
Summary of the quality of evidence according to the Grading of Recommendation Assessment, Development, and Evaluation (GRADE)
Patient or population: Adult patients with expected trauma-induced coagulopathy Settings: In-hospital care Intervention: Patients treated with PCC Comparison: Patients treated without PCC |
Outcomes No of participants (studies) |
Odds ratio | Anticipated absolute effects | Certainty of the evidence (GRADE) | Comments | ||
---|---|---|---|---|---|---|
Without PCC | With PCC | Difference | ||||
Mortality (8 studies, n = 1685) |
0.94 [0.60, 1.45] |
27.2% | 22.4% | − 4.8% |
⊕ ⊝ ⊝ ⊝ Very lowa,b |
May decrease in-hospital mortality |
DVT (6 studies, n = 1497) |
1.00 [0.64; 1.55] |
5.3% | 7.0% | + 1.3% |
⊕ ⊝ ⊝ ⊝ Very Lowa,c,d |
May increase DVT |
aDowngraded because the overall risk of bias for observational studies was serious
bDowngraded because PCC administration was not associated with mortality reduction in the only RCT published
cDowngraded because of the large confidence intervals
dDowngraded because the only RCT did not reported a significant increase of the DVT (but an increase of a composite outcome regrouping the occurrence of at least one thromboembolic event)
DVT deep venous thrombosis, PCC prothrombin complex concentrate