BackgroundIdentification of hypofibrinogenemia is particularly important in obstetrics since this predicts progression to severe Post-Partum Haemorrhage (PPH). ObjectivesTo evaluate the usability of qLabs® FIB at the bedside of patients with PPH. MethodsThe qLabs® FIB test was performed using a drop of whole blood from a citrated laboratory tube sampled from each parturient with PPH >1 L by a trained user. A usability survey was completed by each clinician performing the test. ResultsDuring the evaluation, 101 qLabs® FIB tests were performed. One hundred completed surveys and 58 free comments were collected. Satisfaction was achieved in 84 % of tests. Usability in emergency setting, timeliness of results, and the results display were considered positive. The qLabs® FIB results were obtained in <3 min for concentrations below 3 g/L whilst the median time to paired laboratory results was 60 (20–120) minutes. The lower a patient's fibrinogen level, the faster the qLabs® FIB result. ConclusionThe usability study was the first step in the validation process of the qLabs® FIB point of care device in obstetric settings.

IntroductionReplacement therapy with intravenous (IV) protein C concentrate (Ceprotin®; Baxalta US Inc., a Takeda company, Lexington, MA, USA; Takeda Manufacturing Austria AG, Vienna, Austria) is an approved treatment approach for patients with severe congenital protein C deficiency (SCPCD). Data on the real-world use of protein C concentrate are limited. Materials and methodsIn this non-interventional real-world study, physicians in Europe and the United States (US) with experience using protein C concentrate to treat patients with SCPCD completed an internet-based survey. Information collected included physician clinical practice details, experience treating patients with SCPCD, and opinions on the subcutaneous (SC) administration of protein C concentrate. Physicians responded based on their best recall. ResultsThe analysis included 19 physicians (Europe, n = 12; US, n = 7) who had used protein C concentrate to treat 32 patients with SCPCD. Sixteen patients received IV long-term prophylaxis (LTP; treatment duration ≥3 months) and 12 received SC LTP. Five patients received both IV and SC LTP. Eighteen physicians indicated an interest in adding SC administration to the approved administration routes. ConclusionThis survey shows that LTP with IV protein C concentrate is used in clinical practice by physicians in both Europe and the US for the treatment of patients with SCPCD. Protein C concentrate is also prescribed for SC administration by some physicians in Europe. Although only approved for IV administration, physicians in both Europe and the US indicated an interest in SC administration being an approved administration route for protein C concentrate.