Fibrinogen in the initial resuscitation of severe trauma (FiiRST): a randomized feasibility trial.

BACKGROUND: Decreased plasma fibrinogen concentration shortly after injury is associated with higher blood transfusion needs and mortality. In North America and the UK, cryoprecipitate transfusion is the standard-of-care for fibrinogen supplementation during acute haemorrhage, which often occurs late during trauma resuscitation. Alternatively, fibrinogen concentrate (FC) can be beneficial in trauma resuscitation. However, the feasibility of its early infusion, efficacy and safety remain undetermined. The objective of this trial was to evaluate the feasibility, effect on clinical and laboratory outcomes and complications of early infusion of FC in trauma. METHODS: Fifty hypotensive (systolic arterial pressure ≤100 mm Hg) adult patients requiring blood transfusion were randomly assigned to either 6 g of FC or placebo, between Oct 2014 and Nov 2015 at a tertiary trauma centre. The primary outcome, feasibility, was assessed by the proportion of patients receiving the intervention (FC or placebo) within one h of hospital arrival. Plasma fibrinogen concentration was measured, and 28-day mortality and incidence of thromboembolic events were assessed. RESULTS: Overall, 96% (43/45) [95% CI 86-99%] of patients received the intervention within one h; 95% and 96% in the FC and placebo groups, respectively (P=1.00). Plasma fibrinogen concentrations remained higher in the FC group up to 12 h after admission with the largest difference at three h (2.9 mg dL - 1 vs. 1.8 mg dL - 1; P<0.01). The 28-day mortality and thromboembolic complications were similar between groups. CONCLUSIONS: Early infusion of FC is feasible and increases plasma fibrinogen concentration during trauma resuscitation. Larger trials are justified.

Factors affecting the cement penetration of a hip resurfacing implant: an in vitro study.

An understanding of how the cementing technique influences cement penetration is important for surgeons to plan and conduct hip resurfacing procedures. Therefore the aim of this study is to determine the influence of the following parameters on cement penetration: use of pulse lavage, type of cement, and the standing period of the cement. Nine fresh frozen paired whole cadaver femora were used to investigate cement penetration. The femora were divided into three paired groups: (A) compared the use of pulse lavage to no pulse lavage, (B) compared two low viscosity bone cements SULCEM-3 (Zimmer GmbH, Switzerland) and Surgical Simplex (Stryker Orthopaedics, USA), and (C) compared bone cement viscosities using standing times of 1.5 min. and 3 min. The Durom Hip Resurfacing implant (Zimmer GmbH, Switzerland) was used in all groups. A single slice was taken out of the center of each head. Cement penetration ratio (penetration area divided by the bone area enclosed by implant) and mean cement penetration depth were measured. Cement penetration is increased using pulse lavage, and has the tendency to increase with increasing the cement standing time from 1.5 to 3 min. No difference in cement penetration was found when different cement brands of comparable viscosity were used.

Experimental investigation of threaded cup performance during insertion in total hip replacement.

Cementless threaded cups are often used in Europe on the acetabular side of a total hip arthroplasty (THA), with some products achieving excellent clinical results. Titanium and titanium alloys are nowadays accepted as the materials of choice for these implants. In contrast, however, there is no consensus about the ideal thread design. This in vitro and human cadaver study aimed to compare the insertion torques of commercially available threaded cups during insertion. The aims were (1) to see whether the clinical experience of surgeons using these cups specifically related to insertion torque could be reproduced in the experiment and (2) to assess whether or not the cup size and thread design has a statistically significant influence on the insertion torque. Using a biaxial testing machine the cups were screwed into pre-machined polyurethane blocks and the insertion torque was recorded by an appropriate sensor. Clear differences were seen between the four different designs. A variance analysis using statistical software showed that both the cup size (p=0.003) and the thread design (p=0.0009) significantly affect the insertion torque. The human cadaver study allowing a right-left comparison of two different cups within the same specimen confirmed the insertion torque data of the experimental study. In addition, the trends observed during the course of the insertion agreed with the clinical experience of the orthopaedic surgeons consulted as part of this study. (Hip International 2004; 14: 11-7).

Effects of transgenic Bt corn litter on the earthworm Lumbricus terrestris.

A 200-day study was carried out to investigate the impact of transgenic Bacillus thuringiensis (Bt) corn on immature and adult Lumbricus terrestris in the field and in the laboratory. Another objective of this study was to develop test methods that could be used for standard testing of the impact of transgenic plants on different earthworm species in the field and in the laboratory. For this purpose two different experiments were involved, a laboratory experiment with adult L. terrestris and a field experiment with immature L. terrestris. No lethal effects of transgenic Bt corn on immature and adult earthworms were observed. Immature L. terrestris in the field had a very similar growth pattern when fed either (Bt+) or (Bt-) corn litter. No significant differences in relative weights of (Bt+) and (Bt-) corn-fed adult L. terrestris were observed during the first 160 days of the laboratory trial, but after 200 days adult L. terrestris had a significant weight loss of 18% of their initial weight when fed (Bt+) corn litter compared to a weight gain of 4% of the initial weight of (Bt-) corn-fed earthworms. Further studies are necessary to see whether or not this difference in relative weight was due to the Bt toxin or other factors discussed in the study. Degradation of Cry1Ab toxin in corn residues was significantly slower in the field than at 10 degrees C in the laboratory. Enzyme-linked immunosorbent assay results indicated that earthworms in both experiments were exposed to the Bt toxin throughout the whole experimental time.