Objective
To assess the benefits and safety of early human fibrinogen concentrate in postpartum haemorrhage (PPH) management.
Design
Multicentre, double‐blind, randomised placebo‐controlled trial. Setting: 30 French hospitals.
Population
Patients with persistent PPH after vaginal delivery requiring a switch from oxytocin to prostaglandins.
Methods
Within 30 minutes after introduction of prostaglandins, patients received either 3 g fibrinogen concentrate or placebo.
Main outcome measures
Failure as composite primary efficacy endpoint: at least 4 g/dl of haemoglobin decrease and/or transfusion of at least two units of packed red blood cells within 48 hours following investigational medicinal product administration. Secondary endpoints: PPH evolution, need for haemostatic procedures and maternal morbidity–mortality within 6 ± 2 weeks after delivery.
Results
437 patients were included: 224 received FC and 213 placebo. At inclusion, blood loss (877 ± 346 ml) and plasma fibrinogen (4.1 ± 0.9 g/l) were similar in both groups (mean ± SD). Failure rates were 40.0% and 42.4% in the fibrinogen and placebo groups, respectively (odds ratio [OR] = 0.99) after adjustment for centre and baseline plasma fibrinogen; (95% CI 0.66–1.47; P = 0.96). No significant differences in secondary efficacy outcomes were observed. The mean plasma FG was unchanged in the Fibrinogen group and decreased by 0.56 g/l in the placebo group. No thromboembolic or other relevant adverse effects were reported in the Fibrinogen group versus two in the placebo group.
Conclusions
As previous placebo‐controlled studies findings, early and systematic administration of 3 g fibrinogen concentrate did not reduce blood loss, transfusion needs or postpartum anaemia, but did prevent plasma fibrinogen decrease without any subsequent thromboembolic events.
Tweetable abstract
Early systematic blind 3 g fibrinogen infusion in PPH did not reduce anaemia or transfusion rate, reduced hypofibrinogenaemia and was safe.
Biphasic-flow induced ventilation (BiFIV) is a variable time-cycled tracheal gas insufflation mode, using a specific multiluminal endotracheal tube. Some recent studies have reported efficiency of this new ventilatory mode in experimental in vitro and in vivo settings. We hypothesized that this ventilatory mode could be able to deliver simultaneous efficient ventilation for several animals, using a single ventilator prototype. The study was performed in three groups of three domestic pigs with a normal lung compliance. Each pig was initially anaesthetized, intubated with the specific endotracheal tube, and ventilated with a conventional ventilatory device. The animals were then simultaneously ventilated under BiFIV, using a single ventilator prototype, for each group of three animals. Physiological parameters and arterial blood gases were recorded at each study phase. All animals but one survived the experiment. We did not observe any significant differences in arterial gas exchange, under both ventilatory modes. Oxygenation was as efficient for each three animals ventilated under BiFIV, using a single ventilator device, as under conventional ventilation, using three separate ventilators (PaO2 = 112+/-17 mmHg under conventional ventilation versus 115+/-16 mmHg under BiFIV). In conclusion, variable time-cycled tracheal gas insufflation may allow an efficient multiple ventilation on several animals, using a single multiple output ventilatory device, in a normal lung animal model. If validated on subsequent pathological models, it could thus be interesting in laboratory and/or mass casualty situations.
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