Roeselare, Belgium
Roeselare, Belgium

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Leebeek F.W. G.,Erasmus Medical Center | Tijssen J.G. P.,Academisch Medisch Centrum | Koolen J.,Catharina Ziekenhuis | Stammen F.,AZ Delta | And 9 more authors.
Thrombosis and Haemostasis | Year: 2015

Patients on rivaroxaban requiring percutaneous coronary intervention (PCI) represent a clinical conundrum. We aimed to investigate whether rivaroxaban, with or without an additional bolus of unfractionated heparin (UFH), effectively inhibits coagulation activation during PCI. Stable patients (n=108) undergoing elective PCI and on stable dual antiplatelet therapy were randomised (2:2:2:1) to a short treatment course of rivaroxaban 10 mg (n=30), rivaroxaban 20 mg (n=32), rivaroxaban 10 mg plus UFH (n=30) or standard peri-procedural UFH (n=16). Blood samples for markers of thrombin generation and coagulation activation were drawn prior to and at 0, 0.5, 2, 6–8 and 48 hours (h) after start of PCI. In patients treated with rivaroxaban (10 or 20 mg) and patients treated with rivaroxaban plus heparin, the levels of prothrombin fragment 1 + 2 at 2 h post-PCI were 0.16 [0.1] nmol/l (median) [interquartile range, IQR] and 0.17 [0.2] nmol/l, respectively. Thrombin–antithrombin complex values at 2 h post-PCI were 3.90 [6.8] μg/l and 3.90 [10.1] μg/l, respectively, remaining below the upper reference limit (URL) after PCI and stenting. This was comparable to the control group of UFH treatment alone. However, median values for thrombin–antithrombin complex passed above the URL with increasing tendency, starting at 2 h post-PCI in the UFHalone arm but not in rivaroxaban-treated patients. In this exploratory trial, rivaroxaban effectively suppressed coagulation activation after elective PCI and stenting. © 2015, Schattauer.

Hindryckx P.,Ghent University | Baert F.,AZ Delta | Hart A.,St Marks Hospital | 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.

Drawz S.M.,University of Minnesota | Marschner S.,Terumo BCT | Yanez M.,CHEMCYL | Garcia De Coca A.,Universitario Of Valladolid | And 3 more authors.
Transfusion | Year: 2015

BACKGROUND Mirasol pathogen reduction technology (PRT) treatment inactivates bacteria, viruses, and parasites in plasma products and platelets (PLTs) suspended in plasma and PLT additive solutions (PAS). Few clinical studies exist documenting transfusions with PAS. This study objective was to evaluate the count increments of PRT-treated PAS-C and PAS-E buffy coat (BC) PLTs in routine use observational settings. STUDY DESIGN AND METHODS PLT pools of five or six BCs were collected, processed, and suspended in PAS-C or PAS-E, respectively. Products were exposed to ultraviolet light in the presence of riboflavin and then transfused into 19 patients with hematologic diseases. Patients were monitored for PLT corrected count increment (CCI) at 1 and 24 hours and for any adverse events in the 72 hours after transfusion. Sterility monitoring was performed with a microbial detection system (BacT/ALERT, bioMérieux). RESULTS The PAS-E products had significantly higher PLT concentrations and counts than the PAS-C products. The mean CCIs of per-protocol (PP) units at 1 and 24 hours were 11,900 (n=27) and 5500 (n=30), respectively. Seventy-eight percent of PP transfusions classify as successful with CCIs at 1 hour of higher than 7500, and 63% higher than 4500 at 24 hours. One patient was excluded from all analyses as she was refractory to Mirasol-treated PLT transfusions and follow-up untreated transfusion products. No adverse events were observed and no contaminated products were detected by BacT/ALERT. CONCLUSION PRT-treated BC PLTs in PAS-C or PAS-E demonstrate PLT transfusion success rates in hematology patients with thrombocytopenia that are comparable to previous studies examining PLTs stored in plasma. © 2015 AABB.

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.

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.

Hindryckx P.,Ghent University | Baert F.,AZ Delta | Hart A.,St Marks Hospital | 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.

Trenson S.,University Hospitals Leuven | de Ceuninck M.,AZ Delta
Acta Cardiologica | Year: 2014

Mitral annular calcification is a degenerative process. It is mostly asymptomatic. As the calcification becomes more extensive it might be mistaken for an intracardiac tumour. Mitral annular calcification predicts cardiovascular events, cardiovascular death and overall death. It is predictive of a doubling of the stroke risk. Extensive mitral annular calcification may undergo liquefaction. Surgery is seldom needed.

Terryn S.,AZ Delta | Terryn S.,University Hospitals Leuven | De Medts J.,AZ Delta | De Medts J.,University Hospitals Leuven | Delsupehe K.,AZ Delta
Otolaryngology - Head and Neck Surgery (United States) | Year: 2015

Objective To evaluate what effects treatments of sleep-disordered breathing have on snoring and sleepiness: snoring surgery including osteotomies, mandibular advancement device (MAD), and continuous positive airway pressure (CPAP). Study Design Single-institution prospective comparative effectiveness trial. Setting University-affiliated secondary care teaching hospital. Subjects and Methods We prospectively studied 224 patients presenting with snoring at our department. All patients underwent detailed evaluation, including symptom questionnaires, clinical examination, polysomnography, and drug-induced sleep endoscopy. Based on these results, a treatment was proposed after multidisciplinary consultation. Treatment was evaluated through 4 questionnaires before treatment and 6 weeks and 6 months after. Treatment success was defined as a global snoring visual analog scale score ≤3 at 6 months. Results A total of 195 patients complied with full workup and were proposed treatment. The mean age was 46 ± 11 years; the mean body mass index, 27 ± 4; and the median apnea-hypopnea index, 10.0 (interquartile range, 4.7-20.1). After discussion, 116 (59.5%) patients agreed to start treatment (46%, surgery; 26% MAD; 28% CPAP). All symptom scores, including Epworth Sleepiness Scale, decreased significantly for all treatments at 6 weeks and 6 months. Treatment was successful in 67% of the surgery patients, 67% of the MAD group, and 76% of the CPAP group. Only 6.7% reported an unchanged snoring score in the surgery group, compared with 13.6% in the MAD group and 9.6 % in the CPAP group. Conclusion Multidisciplinary agreed-on treatment of snoring is effective across the proposed treatments. © Official journal of the American Academy of Otolaryngology-Head and Neck Surgery Foundation 2015.

Cleynen I.,Catholic University of Leuven | Van Moerkercke W.,AZ Groeninge | Billiet T.,Catholic University of Leuven | Vandecandelaere P.,AZ Delta | And 11 more authors.
Annals of Internal Medicine | Year: 2016

Background: A subgroup of patients with inflammatory bowel disease (IBD) treated with anti-tumor necrosis factor (TNF) antibodies develop skin lesions, but the lesions and their clinical course are not well-characterized. Objective: To describe patients treated with anti-TNF antibodies who did and did not develop skin lesions. Design: Retrospective cohort. Setting: Single IBD tertiary referral center. Patients: 917 consecutive patients with IBD who initiated anti-TNF therapy. Measurements: Skin lesions, patient demographic characteristics, treatments, clinical course, and serologic and genetic markers. Results: During a median follow-up of 3.5 years (interquartile range [IQR], 0.5 to 7.4 years), skin lesions associated with the use of anti-TNF therapy developed in 264 of 917 (29%) patients (psoriasiform eczema, 30.6%; eczema, 23.5%; xerosis cutis, 10.6%; palmoplantar pustulosis, 5.3%; psoriasis, 3.8%; other, 26.1%). Lesions typically developed at flexural regions, genitalia, and the scalp, especially the psoriasiform lesions. Thirty-one percent of women and 26% of men developed lesions. Median cumulative doses (2864 mg/y [IQR, 2203 to 3819 mg/y] and 2927 mg/y [IQR, 2377 to 3667 mg/y]) and trough levels (4.2 μg/mL [IQR, 2.6 to 5.8 μg/mL] and 4.0 μg/mL [IQR, 1.6 to 5.9 μg/mL]) of infliximab were similar in patients with and without lesions. All but 28 patients (11%) were successfully managed without needing to stop therapy because of lesions. Limitation: Retrospective nature and no matched control group of patients not receiving anti-TNF therapy. Conclusion: Skin lesions occur frequently in association with anti-TNF therapy but rarely require discontinuation of therapy. Close surveillance and early referral to a dedicated dermatologist are recommended. Primary Funding Source: Research Foundation Flanders (FWO), Belgium; Geconcerteerde Onderzoekacties of KU Leuven; and Janssen Biologics. Copyright © 2016 American College of Physicians.

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.

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