Entity

Time filter

Source Type

Roeselare, Belgium

Neyrinck M.M.,AZ Delta | Vrielink H.,Sanquin Blood Supply
Journal of Clinical Apheresis | Year: 2015

It's important to work smoothly with your apheresis equipment when you are an apheresis nurse. Attention should be paid to your donor/patient and the product you're collecting. It gives additional value to your work when you are able to calculate the efficiency of your procedures. You must be capable to obtain an optimal product without putting your donor/patient at risk. Not only the total blood volume (TBV) of the donor/patient plays an important role, but also specific blood values influence the apheresis procedure. Therefore, not all donors/patients should be addressed in the same way. Calculation of TBV, extracorporeal volume, and total plasma volume is needed. Many issues determine your procedure time. By knowing the collection efficiency (CE) of your apheresis machine, you can calculate the number of blood volumes to be processed to obtain specific results. You can calculate whether you need one procedure to obtain specific results or more. It's not always needed to process 3X the TBV. In this way, it can be avoided that the donor/patient is needless long connected to the apheresis device. By calculating the CE of each device, you can also compare the various devices for quality control reasons, but also nurses/operators. © 2014 Wiley Periodicals, Inc. Source


Hindryckx P.,Ghent University | Baert F.,AZ Delta | Hart A.,IBD Unit | Armuzzi A.,Columbus University | And 2 more authors.
Journal of Crohn's and Colitis | Year: 2014

It goes back to 1932 when Dr. Burrill Bernard Crohn and co-workers published their landmark paper, describing regional ileitis as a disease entity. However, clinical trial research has been developing rather slowly in luminal Crohn's disease. It took until the early seventies before the first randomized clinical trial was set up by the National Co-operative Crohn's Disease Study (NCCDS) group. Although the efforts of this group triggered a first wave of clinical trials in Crohn's disease, the lack of guidelines for conducting a clinical trial in this research area resulted in a variety of study designs and much criticism. Besides having a rather small sample size and a short follow-up time, they were often characterized by vague and subjective assessment of disease activity and treatment response.Following the advent of a new and very potent drug class in the late nineties, the anti-TNF agents, investigators started to re-think their study protocols and the first guidelines were set up by the regulatory authorities.Over the last 15. years, clinical trials in luminal Crohn's disease have been evolving significantly. Inclusion criteria have been shifting from clinical scores such as Crohn's Disease Activity Index (CDAI) to more objective disease activity parameters such as biomarkers (C-reactive protein and faecal calprotectin) and endoscopic lesions. Primary endpoints have been developing from clinical response to corticosteroid-free remission and more ambitious end-points such as mucosal healing.In this paper, we will give a historical overview on clinical trials in luminal Crohn's disease, before and within the biologic era, and provide insight into how they have shaped our current understanding of trial designs in Crohn's disease. © 2014 European Crohn's and Colitis Organisation. Source


Hindryckx P.,Ghent University | Baert F.,AZ Delta | Hart A.,IBD Unit | Magro F.,University of Porto | And 2 more authors.
Journal of Crohn's and Colitis | Year: 2015

The clinical trial landscape in ulcerative colitis has evolved significantly in recent decades. Study endpoints have been shifting from mere clinical response to mucosal healing. It has become clear that the choice of combined clinical and endoscopic outcome criteria leads to a reduction in placebo responses, especially when central reading of the endoscopic images is performed. Accumulating evidence suggests that histological remission yields better long-term outcomes for ulcerative colitis patients than mucosal healing alone, and clinical trials with prolonged follow-up will have to address whether histological remission should be the ultimate treatment goal in ulcerative colitis. In recent years there has also been increasing interest in the implementation of patient-reported outcomes in clinical practice and research, and the regulatory authorities have set up guidelines for the development of such outcomes. This paper aims to provide a comprehensive review of historical aspects of clinical trials in ulcerative colitis and to discuss challenges and perspectives for clinical trials in the near future. A thorough analysis of all available landmark literature (both original papers and reviews) on clinical trials in ulcerative colitis was performed. © 2015 European Crohn's and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. Source


In recent years it has become clear that therapeutic drug monitoring can be an important tool to optimize outcome and costs of anti TNF treatment including the subcutaneous and fully human monoclonal antibodies. There is a clear dose response curve between early serum concentrations of all monoclonal antibodies and response both short term and long term. The wide variations in early serum concentrations are insufficiently explained by classic pharmacokinetic factors. Low early concentrations can lead to anti-drug antibody formation and ensuing loss of response. Therapeutic drug monitoring allows to rationalize the current practice of dose optimization and the use of concomitant immunomodulator treatment. However more prospective studies are needed before strong recommendations can enter treatment guidelines. © 2015 S. Karger AG, Basel. Source


Neyrinck M.,AZ Delta | Vrielink H.,Sanquin Blood Supply
Journal of Clinical Apheresis | Year: 2015

A training program for apheresis nurses in leukocyte collection and therapeutic apheresis was developed by the Joint Task Force for Apheresis Education and Certification. This is a modular program with theoretical and practical information and knowledge. On request of the Indonesian authorities, in the capital of Indonesia Jakarta, a certification course for apheresis nurses/operators based on the training program described above was organized in December 2013. The course existed of themes related to apheresis, such as hematology, anatomy, physiology, calculations, adverse events, basics of apheresis, nursing aspects, quality, collection of cells for cellular therapies, pediatrics, and therapeutic collections (cell reductions and exchange procedures). A pretest and post-test regarding the knowledge and judgment in the themes described was taken in Bahasa Indonesia or in English. In total, 38 apheresis nurses and 32 physicians participated in the course. In the post-test, the nurses scored in a mean 72/100 and the physicians 77/100 (nurses vs. physicians: P = 0.005), which was significantly better than the results of the pretest (54/100 and 53/100, respectively (P < 0.0001 for both). In conclusion, with this course, 38 apheresis nurses/operators proved a significant increase of knowledge in the theory behind apheresis. This educational program provides an approach to educate and certificate apheresis nurses. It is also shown that also for physicians working in the field of apheresis, this course is of use increasing their knowledge regarding apheresis. © 2014 Wiley Periodicals, Inc. Source

Discover hidden collaborations