Early fibrinogen concentrate therapy for major haemorrhage in trauma (E-FIT 1): results from a UK multi-centre, randomised, double blind, placebo-controlled pilot trial

• Published in: Critical care (London, England) England), 2018-06, Vol.22 (1), p.164-164, Article 164
• Main Authors: Curry, Nicola, Foley, Claire, Wong, Henna, Mora, Ana, Curnow, Elinor, Zarankaite, Agne, Hodge, Renate, Hopkins, Valerie, Deary, Alison, Ray, James, Moss, Phil, Reed, Matthew J, Kellett, Suzanne, Davenport, Ross, Stanworth, Simon
• Format: Article
• Language: English
• Subjects: Analysis; Care and treatment; Clinical trials; Critical care; Cryoprecipitate; Double-blind studies; Evidence-based medicine; Feasibility studies; Fibrinogen; Fibrinogen replacement therapy; Haemorrhagic shock; Health aspects; Hemorrhage; Hospital admission and discharge; Injuries; Intervention; Laboratories; Mortality; Multiple trauma; Patients; Risk factors; Transfusion; Trauma
• ISSN: 1364-8535; 1466-609X; 1364-8535; 1366-609X
• DOI: 10.1186/s13054-018-2086-x

There is increasing interest in the timely administration of concentrated sources of fibrinogen to patients with major traumatic bleeding. Following evaluation of early cryoprecipitate in the CRYOSTAT 1 trial, we explored the use of fibrinogen concentrate, which may have advantages of more rapid administration in acute haemorrhage. The aims of this pragmatic study were to assess the feasibility of fibrinogen concentrate administration within 45 minutes of hospital admission and to quantify efficacy in maintaining fibrinogen levels ≥ 2 g/L during active haemorrhage. We conducted a blinded, randomised, placebo-controlled trial at five UK major trauma centres with adult trauma patients with active bleeding who required activation of the major haemorrhage protocol. Participants were randomised to standard major haemorrhage therapy plus 6 g of fibrinogen concentrate or placebo. Twenty-seven of 39 participants (69%; 95% CI, 52-83%) across both arms received the study intervention within 45 minutes of admission. There was some evidence of a difference in the proportion of participants with fibrinogen levels ≥ 2 g/L between arms (p = 0.10). Fibrinogen levels in the fibrinogen concentrate (FgC) arm rose by a mean of 0.9 g/L (SD, 0.5) compared with a reduction of 0.2 g/L (SD, 0.5) in the placebo arm and were significantly higher in the FgC arm (p