IntroductionProthrombin complex concentrates (PCC) are haemostatic blood preparations indicated for urgent anticoagulation reversal, though the optimal dose for effective reversal is still under debate. The latest generation of PCCs include four coagulation factors, the so-called 4-factor PCC. The aim of this study was to compare the efficacy and safety of two doses, 25 and 40 IU/kg, of 4-factor PCC in vitamin K antagonist (VKA) associated intracranial haemorrhage.MethodsWe performed a phase III, prospective, randomised, open-label study including patients with objectively diagnosed VKA-associated intracranial haemorrhage between November 2008 and April 2011 in 22 centres in France. Patients were randomised to receive 25 or 40 IU/kg of 4-factor PCC. The primary endpoint was the international normalised ratio (INR) 10 minutes after the end of 4-factor PCC infusion. Secondary endpoints were changes in coagulation factors, global clinical outcomes and incidence of adverse events (AEs).ResultsA total of 59 patients were randomised: 29 in the 25 IU/kg and 30 in the 40 IU/kg group. Baseline demographics and clinical characteristics were comparable between the groups. The mean INR was significantly reduced to 1.2 - and ≤1.5 in all patients of both groups - 10 minutes after 4-factor PCC infusion. The INR in the 40 IU/kg group was significantly lower than in the 25 IU/kg group 10 minutes (P = 0.001), 1 hour (P = 0.001) and 3 hours (P = 0.02) after infusion. The 40 IU/kg dose was also effective in replacing coagulation factors such as PT (P = 0.038), FII (P = 0.001), FX (P <0.001), protein C (P = 0.002) and protein S (0.043), 10 minutes after infusion. However, no differences were found in haematoma volume or global clinical outcomes between the groups. Incidence of death and thrombotic events was similar between the groups.ConclusionsRapid infusion of both doses of 4-factor PCC achieved an INR of 1.5 or less in all patients with a lower INR observed in the 40 IU/kg group. No safety concerns were raised by the 40 IU/kg dose. Further trials are needed to evaluate the impact of the high dose of 4-factor PCC on functional outcomes and mortality.Trial registrationEudra CT number 2007-000602-73.
IntroductionHealth care-associated pneumonia (HCAP) has been proposed as a new category of respiratory infection to identify patients at risk of multidrug-resistant (MDR) pathogens. The American Thoracic Society's recommendation for HCAP treatment is to use broad-spectrum and multiple antibiotics. However, this strategy may be economically expensive and promote antimicrobial resistance when a multisensitive pathogen is not identified.MethodsWe prospectively included all patients presenting with HCAP in the emergency department. Blood cultures and fiberoptic bronchoscope-guided distal protected small volume bronchoalveolar lavage (FODP mini-BAL) were performed in each patient. Empirical antibiotic therapy was adapted when microbiological findings were available. The primary objective was to assess whether FODP mini-BAL is more efficient than blood cultures in identifying pathogens with the ratio of identification between both techniques as principal criteria.ResultsWe included 54 patients with HCAP. Pathogens were identified in 46.3% of cases using mini-BAL and in 11.1% of cases using blood cultures (P <0.01). When the patient did not receive antibiotic therapy before the procedure, pathogens were identified in 72.6% of cases using mini-BAL and in 9.5% of cases using blood cultures (P <0.01). We noted multidrug-resistant pathogens in 16% of cases. All bronchoscopic procedures could be performed in patients without complications.ConclusionsFODP mini-BAL was more efficient than blood cultures for identifying pathogens in patients presenting with HCAP. When bacteriological identification was obtained, antibiotic therapy was adapted in 100% of cases.See related letter by Sircar et al.,http://ccforum.com/content/17/2/428
The criterion of "pre-hospital resuscitation" was statistically significant with the severity of the trauma, but did not increase the PPV. The use of "pre-hospital resuscitation" criterion could be re-considered if these results are confirmed by larger studies.
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