Background: Hypofibrinogenaemia is associated with poor patient outcomes in various clinical settings including trauma, cardiac surgery and obstetric haemorrhage; however, no study to date has combined data from multiple bleeding indications.

Aims: To systematically assess the evidence for the efficacy and safety of fibrinogen supplementation in coagulopathic bleeding patients with low fibrinogen levels, and analyse whether fibrinogen supplementation leads to improved outcomes in these patients.

Methods: EMBASE and PubMed/Medline databases were searched for parallel-group randomised controlled trials with patients receiving fibrinogen supplementation to manage severe haemorrhage due to acquired hypofibrinogenemia (until June 2018). Trials comparing treatment with fibrinogen concentrate (FCH) or cryoprecipitate with any another treatment were eligible; trials involving prophylactic fibrinogen supplementation were excluded. The primary endpoint was patient mortality.

Results: Fifteen studies were identified, including 1195 patients (n=586 received fibrinogen supplementation; n=609 received a comparator). Baseline fibrinogen levels were comparable, and 14 studies used FCH. Bleeding indications included cardiac surgery (n=563; 47.1%), obstetric haemorrhage (n=299; 25.0%) and trauma (n=270; 22.6%). The risk ratio (RR) for in-hospital and/or ≤30-day mortality was 0.57 (14 studies; 95% confidence interval [CI] 0.32-1.02); this result was not significant (p=0.058) but trended towards lower mortality with fibrinogen supplementation versus comparator. A similar pattern was shown for other efficacy endpoints (Figure), with incidence of platelet transfusion associated with significant benefit versus comparator (12 studies; RR 0.68; 95% CI 0.49-0.93; p=0.017). No significant difference was identified in thromboembolic event occurrence between groups (p=0.256). Overall risk of bias was high in all studies.

Conclusions: Results for all endpoints trended in favour of fibrinogen supplementation versus comparator, with no safety signals identified. The significantly reduced incidence of platelet transfusion with fibrinogen supplementation suggests reduced blood loss versus comparator.

Study funded by: CSL Behring. Medical writing support provided by Hanna Mourad-Agha of Fishawack Communications, funded by CSL.

[Summary of efficacy analyses]

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ISTH Congress Abstracts - https://abstracts.isth.org/abstract/fibrinogen-supplementation-in-patients-with-acquired-hypofibrinogenaemia-meta-analysis-and-systematic-review/