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

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.

journal_name

Br J Anaesth

journal_title

British journal of anaesthesia

authors

Curry N,Rourke C,Davenport R,Beer S,Pankhurst L,Deary A,Thomas H,Llewelyn C,Green L,Doughty H,Nordmann G,Brohi K,Stanworth S

doi

10.1093/bja/aev134

subject

Has Abstract

pub_date

2015-07-01 00:00:00

pages

76-83

issue

1

eissn

0007-0912

issn

1471-6771

pii

S0007-0912(17)31243-6

journal_volume

115

pub_type

杂志文章,随机对照试验

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