Fibrinogen concentrate compared to placebo for emergency haemorrhagic event | ||||||
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Patient or population: emergency haemorrhagic event | ||||||
Setting: RCT | ||||||
Intervention: Fibrinogen concentrate | ||||||
Comparison: placebo | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
Risk with placebo | Risk with Fibrinogen concentrate | |||||
In-hospital mortality | 66 per 1000 | 82 per 1000 (42 to 157) | RR 1.24 (0.64 to 2.39) | 522 (6 RCTs) |
Very lowa,b | The evidence suggests fibrinogen concentrate results in a slight increase in in-hospital mortality |
RBC transfusion 24 h | The mean RBC transfusion 24 h ranged from 0.62 to 6.82 Unit | MD 0 Unit (0.99 lower to 0.98 higher) | – | 355 (6 RCTs) |
Very lowa,b,c | Fibrinogen concentrate may reduce/have little to no effect on RBC transfusion 24Â h but the evidence is very uncertain |
FFP transfusion 24 h | The mean FFP transfusion 24 h ranged from 0 to 17.4 Unit | MD 2.61 Unit higher (0.07 higher to 5.16 higher) | – | 295 (5 RCTs) |
Lowb,c | Fibrinogen concentrate probably increases FFP transfusion 24Â h |
PC transfusion 24 h | The mean PC transfusion 24 h ranged from 0.64 to 2.98 Unit | MD 0.46 Unit higher (0.17 higher to 0.76 higher) | – | 187 (3 RCTs) |
Moderateb | Fibrinogen concentrate likely results in a large increase in PC transfusion 24Â h |
Blood loss within 24 h | The mean blood loss within 24 h was 221.8 mL | MD 171 mL lower (400.35 lower to 58.35 higher) | – | 55 (1 RCT) |
Lowd | Fibrinogen concentrate may result in little to no difference in blood loss within 24Â h |
Thrombotic events | 53 per 1000 | 38 per 1000 (17 to 83) | RR 0.71 (0.32 to 1.58) | 529 (6 RCTs) |
Very lowa,b | Fibrinogen concentrate likely results in little to no difference in thrombotic events |
Multiple organ failure | 500 per 1000 | 270 per 1000 (90 to 780) | RR 0.54 (0.18 to 1.56) | 154 (2 RCTs) |
Lowa,b | Fibrinogen concentrate may result in a slight reduction in multiple organ failure |