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Dijon, France

Kerebel D.,French Army Hospital Sainte Anne | Joly L.-M.,CHU Rouen | Honnart D.,CHU Dijon | Schmidt J.,CHU Clermont Ferrand | And 4 more authors.
Critical Care | Year: 2013

Introduction: Prothrombin 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.Methods: We 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).Results: A 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.Conclusions: Rapid 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 registration: Eudra CT number 2007-000602-73. © 2013 Kerebel et al.; licensee BioMed Central Ltd. Source

Pierot L.,Reims University Hospital Center | Cognard C.,Toulouse University Hospital Center | Ricolfi F.,CHU Dijon | Anxionnat R.,Nancy University Hospital Center
American Journal of Neuroradiology | Year: 2010

BACKGROUND AND PURPOSE: The efficacy of the endovascular treatment in providing stable occlusion of intracranial aneurysms is still controversial and should be precisely analyzed. A first step is to carefully study immediate anatomical results. CLARITY (Clinical and Anatomical Results in the Treatment of Ruptured Intracranial Aneurysms) is a prospective multicenter consecutive series including patients treated by coiling for ruptured aneurysms. Immediate anatomic results are presented. MATERIALS AND METHODS: Postoperative anatomic results were evaluated by DSA by the treating physician and anonymously and independently by 2 experienced neuroradiologists by using the 3-point Montreal Scale. Patients were divided into 2 groups: patients treated with GDC and those treated with Matrix detachable coils. RESULTS: A total of 773 patients (461 women, 312 men; 19-80 years of age; mean, 51.2 ± 13.2 years) with 773 ruptured aneurysms were included in the study. The rate of occlusion as determined by the treating physician was designated complete for 586 aneurysms (75.8%), neck remnant for 145 aneurysms (18.8%), and aneurysm remnant for 42 aneurysms (5.4%). The same evaluation as reported by the 2 independent reviewers was complete occlusion for 366 aneurysms (47.4%), neck remnant for 324 aneurysms (41.9%), and aneurysm remnant for 83 aneurysms (10.7%). Postoperative anatomic results were significantly linked to age but not to the technique of endovascular treatment or aneurysm characteristics (location, size, dome-to neck ratio). Results were not significantly different between the GDC and Matrix group. CONCLUSIONS: Endovascular treatment of ruptured intracranial aneurysms resulted in a high rate of satisfactory occlusion (complete occlusion and neck remnant in 89.3%). Patient age was the only factor associated with the rate of occlusion. The rate of aneurysm occlusion differed insignificantly between GDC and Matrix coils. Source

Cognard C.,Toulouse University Hospital Center | Pierot L.,Reims University Hospital Center | Anxionnat R.,Nancy University Hospital Center | Ricolfi F.,CHU Dijon
Neurosurgery | Year: 2011

Background: The International Subarachnoid Aneurysm Trial (ISAT) showed that for ruptured aneurysms suitable for both techniques, coiling should be the first-choice treatment. Only a small proportion of patients (22%) with ruptured aneurysms were included in that trial. Operators were selected on their experience. One could then criticize the impact of the ISAT on clinical practice as a result of recruitment biases and operators' selection. Objective: To evaluate the morbidity and mortality of coiling when used as first-choice treatment in a consecutive population of patients with ruptured aneurysms treated by nonselected operators. Methods: Thirty-four operators from 19 French centers treated 405 patients with GDC coils from November 2006 to July 2007. The method of treatment was not prespecified. Results: World Federation of Neurological Societies grade at admission was I/II in 65.7% and IV/V in 30.6% of patients. At the 3- to 6-month follow-up, 23.3% of patients were dependent or dead. Thromboembolic events and intraoperative rupture resulted in permanent deficit in 13 (3.2%) and 2 (0.5%), respectively, and death in 4 (1.0%) and 0. Early rebleeding occurred in 2 patients (0.5%) with 2 subsequent deaths. Permanent treatment morbidity and mortality were 3.7 % and 1.5 %, respectively. Conclusion: Clinical results of the multicenter prospective Clarity registry show that when coiling is performed as first-intention treatment in a consecutive series of nonselected ruptured aneurysms by nonselected operators, clinical results are similar to those of the ISAT. Copyright © 2011 by the Congress of Neurological Surgeons. Source

Lafon A.,CHU Dijon | Lafon A.,University of Reims Champagne Ardenne | Pereira B.,University Hospital of Clermont Ferrand | Dufour T.,University of Western Brittany | And 4 more authors.
European Journal of Neurology | Year: 2014

This review aimed to determine the association between periodontal disease and stroke incidence by a meta-analysis of cohort studies. Cohort studies that evaluated the incidence of stroke (fatal or non-fatal, ischaemic or haemorrhagic) and baseline periodontal status and calculated relative risk values were included. The quality of the included studies was assessed using an evaluation grid. The analyses were conducted separately for three outcomes: periodontitis, gingivitis and loss of teeth. Adjusted values of relative risk or of hazard ratio were used to assess risk values in each study. Random effects meta-analyses were conducted when data could be pooled. From the 743 references retrieved, only nine cohort studies were suitable for inclusion in this review. Quality scores of the studies varied greatly. Three prospective studies, which used reliable indicators of periodontal disease, obtained the highest scores. Conversely, three studies that used a subjective evaluation of stroke incidence or diagnosed stroke without imaging obtained the lowest score. The results of the meta-analyses varied depending on the outcome considered and the type of stroke. The risk of stroke was significantly increased by the presence of periodontitis [relative risk 1.63 (1.25, 2.00)]. Tooth loss was also a risk factor for stroke [relative risk 1.39 (1.13, 1.65)]. The risk of stroke did not vary significantly with the presence of gingivitis. This review shows that periodontitis and tooth loss are associated with the occurrence of stroke. © 2014 EAN. Source

Pham-Ledard A.,University of Bordeaux 1 | Pham-Ledard A.,Bordeaux University Hospital Center | Prochazkova-Carlotti M.,University of Bordeaux 1 | Andrique L.,University of Bordeaux 1 | And 10 more authors.
Modern Pathology | Year: 2014

Primary cutaneous large B-cell lymphoma, leg type has been individualized from nodal diffuse large B-cell lymphoma. The objective of this study was to screen primary cutaneous large B-cell lymphoma, leg type for genetic alterations recently described in nodal diffuse large B-cell lymphoma. Skin biopsies from 23 patients were analyzed for IRF4, BCL2, BCL6, and MYC expression. FISH testing was performed for BCL2, BCL6, MYC with separation probes and for CDKN2A and PRDM1/BLIMP1 deletion. Multiple sequential FISH analyses with up to six probes were performed to define samples with multiple cytogenetic alterations. MYD88 mutations were studied by Sanger sequencing. All cases but one displayed at least one genetic alteration (96%). Nine patients exhibited a single genetic mutation and 12 combined several alterations (52%). We observed a split for BCL2, BCL6, or MYC in 1/23, 6/23, and 3/23 of cases, respectively. No double-hit lymphoma was observed. CDKN2A deletion was detected by FISH in only 5/23 cases. BLIMP1 and/or 6q deletion was observed at a higher rate in 10/20 of cases. No correlation between rearrangement and immunohistochemical expression was found for BCL2 or MYC. FISH tracking of sequential hybridizations showed that several alterations were carried by the same nuclei. The p.L265P MYD88 mutation was found in 11/18 (61%) of cases. Contrary to most cutaneous lymphomas that rarely harbor primary genetic alteration of their nodal histological equivalent, primary cutaneous large B-cell lymphoma, leg type seems to be a 'cutaneous counterpart' of activated B-cell-like diffuse large B-cell lymphoma with a similar cytogenetic profile and a high rate of MYD88 oncogenic L265P mutation. This also suggests a common lymphomagenesis with NF-κB activation, strong IRF4 expression and terminal B-cell differentiation blockage. Our data support the use of therapies targeting NF-κB, as most patients displayed disease progression and resistance to conventional therapies. © 2014 USCAP, Inc All rights reserved. Source

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