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Selected AbstractsThe safety and efficacy of an extravascular, water-soluble sealant for vascular closure: Initial clinical results for MynxÔCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 5 2007D. Scheinert MD Abstract Objective: The purpose of this study was to evaluate the hemostatic efficacy and safety of the Mynx extravascular sealant for femoral artery closure. Background: The Mynx device is an extra-arterial vascular closure technology utilizing a water-soluble, porous, polyethylene glycol matrix that immediately seals the arteriotomy by rapidly absorbing subcutaneous fluids and expanding in the tissue tract and then, resorbs within 30 days. Methods: The Mynx study was a prospective, multicenter, single-arm clinical investigation conducted at five European centers. The safety and effectiveness of the Mynx device was evaluated in patients following diagnostic or interventional endovascular procedures performed through 5 Fr, 6 Fr, or 7 Fr introducer sheaths in the common femoral artery. The primary safety endpoint was the combined rate of major complications within 30 days (±7 days). The primary efficacy endpoints were time to hemostasis and time to ambulation. Results: Patient enrollment included 190 patients with 50% having undergone diagnostic catheterization and 50% interventional procedures with a mean activated clotting time of 221 sec. One (0.5%) major vascular complication (transfusion) occurred in one patient. No device-precipitated complications associated with serious clinical sequelae were reported. Mean (± standard deviation) times to hemostasis and ambulation were 1.3 ± 2.3 min and 2.6 ± 2.6 hr, respectively. There was no significant difference in median times to hemostasis between diagnostic and interventional patients (0.5 vs. 0.6 min). Conclusions: The initial experience with the extra-arterial Mynx closure technology supports hemostatic safety and efficacy in patients undergoing diagnostic and interventional catheterization procedures. © 2007 Wiley-Liss, Inc. [source] Ability of Patients to Accurately Recall the Severity of Acute Painful EventsACADEMIC EMERGENCY MEDICINE, Issue 3 2001Adam J. Singer MD Abstract. Objective: Pain studies require prospective patient enrollment to ensure accurate pain assessment. The authors correlated pain assessments of an acute painful episode over a one-week period and determined the accuracy of patient pain severity recall over time. Methods: This was a prospective, descriptive, longitudinal study. Participants were a convenience sample of 50 emergency department patients with acute pain resulting from injuries or painful invasive procedures. A trained research assistant administered a structured pain survey containing demographic and historical features to all patients. Patients sequentially assessed their pain severity using a vertical 100-mm visual analog scale marked "most pain" at the top, a verbal numeric rating scale ranging from 0 to 100 from none to worst (NRS100), and a verbal numeric rating scale ranging from 0 to 10 from none to worst (NRS10). Patients were contacted by phone and asked to reassess their initial pain severity one and seven days later using the two verbal numeric rating scales. Analysis of pain assessments using the various scales at the three time intervals was performed with Pearson's and Spearman's coefficients and repeated-measures analysis of variance (ANOVA). Results: There were 50 patients with a mean age of 41 years. Correlation between initial pain assessments on the three scales ranged from 0.83 to 0.92. Correlations between the initial and 24-hour assessments were NRS100-0.98 and NRS10-0.98. Correlations between the initial and one-week assessments were NRS100-0.96 and NRS10-0.97. Repeated-measures ANOVA showed no significant change in pain assessments over time for both verbal numeric scales. Conclusions: Pain severity assessments of acute painful events one and seven days later were similar and highly correlated with initial assessments using both verbal numeric scales. Patients accurately recall the severity of an acute painful episode for at least one week after its occurrence, which may allow retrospective pain assessments. [source] Rationale and Design of ATHENA: A Placebo-Controlled, Double-Blind, Parallel Arm Trial to Assess the Efficacy of Dronedarone 400 mg Bid for the Prevention of Cardiovascular Hospitalization or Death from Any Cause in PatiENts with Atrial Fibrillation/Atrial FlutterJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 1 2008STEFAN H. HOHNLOSER M.D. Background: Atrial fibrillation (AF) is the most commonly encountered clinical arrhythmia, predominantly affecting elderly patients. There is a continued need for new antiarrhythmic drugs to treat the ever-increasing number of patients with this arrhythmia. Dronedarone is a new antiarrhythmic compound currently being developed for treatment of AF. Methods: The ATHENA trial (A placebo-controlled, double-blind, parallel arm Trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter) is the largest single antiarrhythmic drug trial ever conducted. More than 4,600 patients with a history of AF or atrial flutter (AFL) have been randomized to receive dronedarone 400 mg bid or matching placebo. The primary study endpoint is time to first cardiovascular hospitalization or death from any cause. The study has completed patient enrollment in December 2006 and is expected to end follow-up 1 year later. Conclusion: ATHENA will be the largest efficacy and safety trial of dronedarone, a multichannel blocker compound with properties from class I, II, III, and IV antiarrhythmic drugs developed to treat patients with AF. [source] The role of immunomodulation in ABO-incompatible adult liver transplant recipientsJOURNAL OF CLINICAL APHERESIS, Issue 2 2008Lucio Urbani Abstract Background: ABO-incompatible (ABO-i) liver transplantation (LT) is a high-risk procedure due to the potential for antibody-mediated rejection (AMR) and cell-mediated rejection. The aim of the current report is to illustrate the results of a retrospective comparison study on the use of immunomodulation with therapeutic plasma exchange (TPE) associated to high-dose immunoglobulins (IVIg) and extracorporeal photopheresis (ECP) in ABO-i adult LT patients. Patients and methods: Between January 1996 and December 2005, 19 patients underwent ABO-i LT. The study was designed for a comparison between two groups of ABO-i LT. Group 1 (control group) consisted of 11 patients treated with TPE only. Group 2 (study group) included eight patients treated with TPE and IVIg. Moreover, all Group 2 patients received acute rejection prophylaxis with ECP. Results: The graft survival at 6, 12, and 18 months was 63.6, 54.4, and 45.5% for Group 1 vs. 87.5, 87.5, and 87.5% for Group 2 (P , 0.001). In Group 1 there were 3(27.3%) cases of AMR; 5 (45.4%) biopsy-proven acute rejections (BPAR); 1 (9.1%) chronic rejection and 3 (27.3%) ischemic-type biliary lesions (ITBL). In Group 2 there were no cases of AMR, BPAR, chronic rejection, or ITBL (P = 0.013). Conclusion: At median follow-up of 568 days, TPE in combination with IVIg and ECP appears to protect the graft from AMR in ABO-i liver transplantation. Continued patient enrollment will allow validation of these preliminary observations or the opportunity to devise newer AMR-avoidance policies. J. Clin. Apheresis 2008. © 2008 Wiley-Liss, Inc. [source] Evaluation of the feasibility of and results of measuring health-status changes in patients undergoing surgical treatment for skeletal metastasesJOURNAL OF ORTHOPAEDIC RESEARCH, Issue 1 2000Denis R. Clohisy The goal of treating patients with skeletal metastases is to decrease pain and improve or maintain physical function. Assessment of the effectiveness of treatment should therefore include evaluation of patient-rated measures of quality of life. The primary objective of the study was to determine the feasibility of studying the effect of surgical treatment of skeletal metastases on quality of life. The secondary objective was to provide data that begin to characterize this effect. The characteristics of patients with skeletal metastases are heterogeneous, patient enrollment in the study may be low, high attrition occurs secondary to death, and well accepted health-status measures (such as the Short Form-36) may be ineffective at detecting changes in health status: therefore, it is difficult to study these patients. High attrition and adjuvant treatment with radiation or chemotherapy made it impractical to draw firm conclusions about the effect of surgical treatment, but a trend toward improvement in selected health-status measures for both physical and mental health was noted. Analysis of patient-rated health-status scores as predictors of survival indicates that improvement in these scores 6 weeks after surgery is associated with an increase in the length of survival following surgery. [source] In Vitro and In Silico Analysis of Annexin V Binding to Lymphocytes as a Biomarker in Emergency Department Sepsis StudiesACADEMIC EMERGENCY MEDICINE, Issue 9 2007Colin F. Greineder Background: Peripheral blood lymphocyte apoptosis is a recognized feature of serious infection and sepsis and can be easily quantified by flow cytometric measurement of annexin V binding to the cell surface. Use of apoptosis as a biomarker in emergency department (ED) studies of sepsis is potentially difficult because of sample processing requirements and limited availability of a research cytometer with which to measure patient samples. Objectives: To assess, in vitro and in simulation, the relationship between sample stability, timing of patient enrollment, and diagnostic performance of a flow cytometric assay for sepsis in patients evaluated in EDs. Methods: Assuming any clinical trial would require daily sample batching, the authors measured the stability of lymphocyte samples over time, noting the rate at which annexin V,negative cells became positive as ED processing delays increased. With these data, they then optimized a study design that could evaluate lymphocyte apoptosis as a sepsis biomarker by using a series of Monte Carlo,based simulated clinical trials. Results: The authors found that annexin V,negative lymphocytes become positive during storage delays that would be encountered in an ED sepsis trial. The extent of this deterioration was least among cells left as whole blood at room temperature until just before analysis or when lymphocytes were isolated early and stored in culture media at 4°C until analysis. When the expected rate of sample deterioration was considered in simulated clinical trials, an inverse relationship was found between the rate at which patients are enrolled and the best achievable receiver operating characteristic curve a study could produce. Conclusions: Peripheral blood samples being analyzed for lymphocyte apoptosis degrade at a rate relevant to the design of ED trials of sepsis. Because of sample processing delays inherent in studying unscheduled septic patients, the performance of annexin V binding as a biomarker for sepsis can approach, but not be expected to exceed, its performance in a comparable intensive care unit,based study. [source] 2007 SAEM Annual Meeting AbstractsACADEMIC EMERGENCY MEDICINE, Issue 2007Article first published online: 5 SEP 200 The editors of Academic Emergency Medicine are pleased and privileged to present the Original Research Abstracts from the Annual Meeting of the Society for Academic Emergency Medicine, May 16,19, 2007, in Chicago. The exciting trends of emergency medicine research are reflected in these brief summaries as are the talent, creativity, and enthusiasm of novice as well as more experienced academicians. This year, 1,172 research abstracts were submitted and 545 were selected for presentation at the Meeting (not including the 78 Innovations in Emergency Medicine Education Exhibits, which were submitted sepa-rately). Each abstract was independently reviewed by up to six designated topics experts who were blinded to the authors. Final determination for scientific presentation was made by the Scientific Subcommittee, chaired by O. John Ma, MD, and the SAEM Program Committee, chaired by Debra Houry, MD, MPH. The decision for presentation was based on the final review score and the space available for presentation at the meeting. We present these abstracts as they were received electronically from the authors, who are solely responsible for their content. They appear as they were received; we have done only minimal proofreading of these abstracts. Any questions you may have on their content should be directed to their authors. Presentation numbers precede the abstract titles. An index of key words and authors begins on page S220. Abstracts marked as late breakers (numbers 462 and 527) are prospective research projects, such as a clinical trial still in the midst of data collection or patient enrollment at the January 8 abstract deadline, but that will be completed, including analysis, by April 15, 2007. On behalf of the membership of SAEM, the editorial board of AEM, and the leadership of our specialty, we express our sincere gratitude to these academicians and the SAEM Program Committee for their continuing efforts to improve our patients' care by advancing emergency medicine research and education. [source] | ||||||||||