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Table 2 Summary of findings

From: Emergency administration of fibrinogen concentrate for haemorrhage: systematic review and meta-analysis

Fibrinogen concentrate compared to placebo for emergency haemorrhagic event

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 24 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 24 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 24 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 24 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

  1. *The risk in the intervention group (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)
  2. CI—Confidence interval; MD—Mean difference; RR—Risk ratio
  3. GRADE Working Group grades of evidence
  4. High certainty We are very confident that the true effect lies close to that of the estimate of the effect
  5. Moderate certainty We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
  6. Low certainty Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
  7. Very low certainty We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect
  8. aDue to moderate weight of high risk of bias
  9. bDue to low events number for optimal information size
  10. cDue to high heterogeneity
  11. dDue to very low events number for optimal information size