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Br J Anaesth. 2015 Jul;115(1):76-83. doi: 10.1093/bja/aev134. Epub 2015 May 19.

Early cryoprecipitate for major haemorrhage in trauma: a randomised controlled feasibility trial.

Author information

1
Department of Haematology, Oxford University Hospitals NHS Trust, John Radcliffe Hospital, Oxford, UK nicola.curry@ouh.nhs.uk.
2
Centre for Trauma Sciences, Barts and the London School of Medicine & Dentistry, Queen Mary University of London, London, UK.
3
Department of Haematology, Oxford University Hospitals NHS Trust, John Radcliffe Hospital, Oxford, UK.
4
NHS Blood and Transplant Clinical Trials Unit, NHS Blood & Transplant, Cambridge and Bristol, UK.
5
Department of Haematology, Barts Health NHS Trust, London, UK.
6
NHS Blood and Transplant, Birmingham, UK.
7
Plymouth Hospitals NHS Trust, Plymouth, UK The Academic Department of Military Anaesthesia and Critical Care, Royal Centre for Defence Medicine, Birmingham, UK.

Abstract

BACKGROUND:

Low fibrinogen (Fg) concentrations in trauma haemorrhage are associated with poorer outcomes. Cryoprecipitate is the standard source for Fg administration in the UK and USA and is often given in the later stages of transfusion therapy. It is not known whether early cryoprecipitate therapy improves clinical outcomes. The primary aim of this feasibility study was to determine whether it was possible to administer cryoprecipitate, within 90 min of admission to hospital. Secondary aims were to evaluate laboratory measures of Fg and clinical outcomes including thrombotic events, organ failure, length of hospital stay and mortality.

METHODS:

This was an unblinded RCT, conducted at two civilian UK major trauma centres of adult trauma patients (age ≥16 yrs), with active bleeding and requiring activation of the major haemorrhage protocol. Participants were randomised to standard major haemorrhage therapy (STANDARD) (n=22), or to standard haemorrhage therapy plus two early pools of cryoprecipitate (CRYO) (n=21).

RESULTS:

85% (95% CI: 69-100%) CRYO participants received cryoprecipitate within 90 min, median time 60 min (IQR: 57-76) compared with 108 min (67-147), CRYO and STANDARD arms respectively (P=0.002). Fg concentrations were higher in the CRYO arm and were maintained above 1.8 g litre(-1) at all time-points during active haemorrhage. All-cause mortality at 28 days was not significantly different (P=0.14).

CONCLUSIONS:

Early Fg supplementation using cryoprecipitate is feasible in trauma patients. This study supports the need for a definitive RCT to determine the effect of early Fg supplementation on mortality and other clinical outcomes.

TRIAL REGISTRY NUMBER:

ISRCTN55509212.

KEYWORDS:

cryoprecipitate; fibrinogen; haemorrhagic shock; multiple trauma

PMID:
25991760
DOI:
10.1093/bja/aev134
[Indexed for MEDLINE]
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