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Hemophilia A is caused by a deficiency in blood coagulation Factor (F)VIII. Treatment for acute bleeding in patients comprises prophylactic infusion with human plasma-derived (pd) or recombinant (r)FVIII to increase circulating FVIII levels. However, alloantibodies (inhibitor) may arise in patients, limiting the efficacy of replacement therapy, especially in patients who develop high-titer inhibitors. For these patients, FVIII-bypassing agents are proposed, but there is a rare risk of thrombotic events. Porcine pdFVIII successfully achieves hemostatic FVIII levels in patients in whom human FVIII was ineffective, but possible residual viral contamination and immunogenicity prevents routine use. OBI-1, being developed by Ipsen and Inspiration Biopharmaceuticals Inc, is a bioengineered form of porcine rFVIII that is highly purified. OBI-1 has the procoagulant and biochemical properties of porcine pdFVIII, with improvements in risk of toxicity, infection and ease of manufacture. OBI-1 demonstrated significantly less immunogenicity than pdFVIII in a murine model of hemophilia A. Moreover, in cynomolgus monkeys, OBI-1 did not generate detectable inhibitors. OBI-1 was effective in a phase II, open-label clinical trial in patients with hemophilia A and inhibitor against porcine FVIII, who were experiencing a non-life or -limb threatening bleed. OBI-1 was well tolerated, without drug-related serious adverse events and is promising for further studies. © 2010 Thomson Reuters (Scientific) Ltd.

Ausenda C.D.,San Carlo Borromeo Hospital | Carnovali M.,Passirana Hospital
European Journal of Physical and Rehabilitation Medicine | Year: 2011

Background: Bilateral transfer of a motor skill is a phenomenon based on the observation that the performance of a skill with one hand can "teach" the same skill to the other hand. Aim: In this study the ability of bilateral transfer to facilitate the motor skill of the paretic hand in patients that suffered a stroke was tested. Design: In a randomized controlled trial subjects were randomly assigned to either the test group or the control group. Setting: The experiment was performed in a general hospital rehabilitation facility for inpatients and outpatients. Population: We studied 20 outpatients, who had their first stroke episode characterized by a brain lesion to a single hemisphere, at the end of their rehabilitation treatment. The criteria used for the selection were based on a physical examination, the time elapsed from the stroke and cognitive requirements. Methods: The experiment consisted in training the healthy hand of each patient from the test group to execute the nine hole peg test 10 times a day, for three consecutive days, and then test the paretic hand with the same test and with bimanual tasks. The control group was not trained but went through the same analysis. Results: The homogeneity of the two groups has been proven. In the test group we found that the execution speed of the nine hole peg test with the paretic hand, after training the healthy hand, was on average 22.6% faster than the value recorded at baseline. The training had a positive effect on the execution of bimanual tasks. Meanwhile, no significant difference was found in the control group. Conclusion: This is the first evidence that bilateral transfer of motor skills is present in patients that suffered a stroke, and that it improves the ability of the affected hand. Clinical rehabilitation impact: This observation could open the way to the development of a new approach for the rehabilitation of stroke patients.

Bernocchi P.,Fondazione Salvatore Maugeri | Scalvini S.,Fondazione Salvatore Maugeri | Tridico C.,Health Directorate | Borghi G.,CEFRIEL | And 4 more authors.
American Journal of Managed Care | Year: 2012

Objectives: To verify implementation and use of TELEMACO (TELEMedicina Ai piccoli COmunilombardi; http://www.telemaco.regione.lombardia.it/), which provides specialized continuity of care with innovative healthcare services in remote areas of the Lombardy region of Italy; to design a network in the territory for sharing of continuityof- care programs; and to allow the relevant health authorities to collect cost data to establish a model for sustainable pricing for implementing these services. Methods: TELEMACO provides home-based telemanagement services for patients with chronic heart failure and chronic obstructive pulmonary disease (COPD), as well as second-opinion teleconsultations in cardiology, dermatology, diabetology, and pulmonology for general practitioners and second-opinion teleconsultations on digital images in cases of traumatic brain injury and stroke. A total of 2 service centers, 10 cardiology and pneumology departments, 30 specialists, 176 general practitioners, 40 nurses, 2 emergency departments, and 2 consultant hospitals were involved. Results: A total of 166 patients with chronic heart failure and 474 patients with COPD were enrolled. There were 4830, 51, and 44 secondopinion teleconsultations for cardiologic, dermatologic, and diabetic conditions, respectively. There were 147 second-opinion teleconsultations on digital images, 68 for stroke, and 79 for traumatic brain injury. Implementation of TELEMACO introduced innovations in working methods and provided evidence to the health authorities for allocating funds for such services. Conclusions: TELEMACO provided evidence that there is a growing need for home management of patients using telemedicine, a common and efficacious approach that can ensure care continuity, especially in chronic diseases.

Davidson I.J.A.,University of Texas Southwestern Medical Center | Lok C.,University of Toronto | Dolmatch B.,University of Texas Southwestern Medical Center | Gallieni M.,San Carlo Borromeo Hospital | And 4 more authors.
Seminars in Nephrology | Year: 2012

Evolving new technologies in vascular access mandate increased attention to patient safety; an often overlooked yet valuable training tool is simulation. For the end-stage renal disease patient, simulation tools are effective for all aspects of creating access for peritoneal dialysis and hemodialysis. Based on aviation principles, known as crew resource management, we place equal emphasis on team training as individual training to improve interactions between team members and systems, cumulating in improved safety. Simulation allows for environmental control and standardized procedures, letting the trainee practice and correct mistakes without harm to patients, compared with traditional patient-based training. Vascular access simulators range from suture devices, to pressurized tunneled conduits for needle cannulation, to computer-based interventional simulators. Simulation training includes simulated case learning, root cause analysis of adverse outcomes, and continual update and refinement of concepts. Implementation of effective human to complex systems interaction in end-stage renal disease patients involves a change in institutional culture. Three concepts discussed in this article are as follows: (1) the need for user-friendly systems and technology to enhance performance, (2) the necessity for members to both train and work together as a team, and (3) the team assigned to use the system must test and practice it to a proficient level before safely using the system on patients. © 2012 Elsevier Inc.

Vedovati M.C.,University of Perugia | Becattini C.,University of Perugia | Agnelli G.,University of Perugia | Kamphuisen P.W.,University of Groningen | And 10 more authors.
Chest | Year: 2012

Background: In patients with acute pulmonary embolism (PE), the correlation between the embolic burden assessed by multidetector CT (MDCT) scan and clinical outcomes remains unclear. Patients with symptomatic acute PE diagnosed based on MDCT angiography were included in a multicenter study aimed at assessing the prognostic role of the embolic burden evaluated with MDCT scan. Methods: Embolic burden was assessed as (1) localization of the emboli as central (saddle or at least one main pulmonary artery), lobar, or distal (segmental or subsegmental arteries) and (2) the obstruction index by the scoring system of Qanadli. The primary outcome was 30-day all-cause death or clinical deterioration. Predictors of all-cause death or clinical deterioration were identified by Cox regression statistics. Results: Overall, 579 patients were included in the study; 60 (10.4%) died or had clinical deterioration at 30 days. Central localization of emboli was not associated with all-cause death or clinical deterioration (hazard ratio [HR], 2.42; 95% CI, 0.77-7.59; P = .13). However, in 516 hemodynamically stable patients, central localization of emboli (HR, 8.3; 95% CI, 1.0-67; P = .047) was an independent predictor of all-cause death or clinical deterioration, whereas distal emboli were inversely associated with these outcome events (HR, 0.12; 95% CI, 0.015-0.97; P = .047). No correlation was found between obstruction index (evaluated in 448 patients) and all-cause death or clinical deterioration in the overall study population and in the hemodynamically stable patients. Conclusions: In hemodynamically stable patients with acute PE, central emboli are associated with an increased risk for all-cause death or clinical deterioration. This risk is low in patients with segmental or subsegmental PE. © 2012 American College of Chest Physicians.

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