Early cryoprecipitate for major haemorrhage in trauma: a randomised controlled feasibility trial
British Journal of Anaesthesia. 2015;115((1)):76-83.
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.Copyright © The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: firstname.lastname@example.org.
Fibronectin in severe sepsis
Surgery, Gynecology & Obstetrics. 1986;162((3):):222-8.
Fibronectin was given in the form of cryoprecipitate of human plasma to patients with severe surgical sepsis in a double blind, prospective and randomized clinical study. Of the 19 patients assigned to the control group receiving no fibronectin, only eight (42 per cent) survived. Of the 12 patients given the cryoprecipitate, nine survived (75 per cent) (p less than 0.05). In the control group, initial serum fibronectin levels were depressed to 121 micrograms per milliliter (normal = 313). The mean values in the blank plasma controls did not increase after 24 hours, with a mean of 122. In contrast, the group treated with cryoprecipitate increased serum fibronectin values after 24 hours to 216 micrograms per milliliter, up from initial values of 161 micrograms per milliliters. Improvements in pulmonary function, serum bilirubin and serum creatinine values were also noted, but the changes fell short of statistical significance. Fibronectin appears to benefit patients in severe surgical sepsis in this study of a relatively small number of patients.