UvA-DARE (Digital Academic Repository) Clinical evaluation of Duraflo ® II heparin treated extracorporeal circulation circuits (2nd version) The European working group on heparin coated extracorporeal circulation circuits

Published in: European journal of cardio-thoracic surgery DOI: 10.1016/S1010-7940(96)01122-0 Link to publication Citation for published version (APA): Wildevuur, C. R. H., Jansen, P. G. M., Bezemer, P. D., Kuik, D. J., Eijsman, L., Bruins, P., ... Ahlvin, E. (1997). Clinical evaluation of Duraflo? II heparin treated extracorporeal circulation circuits (2nd version) the European working group on heparin coated extracorporeal circulation circuits. European journal of cardio-thoracic surgery, 11, 616-623. https://doi.org/10.1016/S1010-7940(96)01122-0 General rights It is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an open content license (like Creative Commons). Disclaimer/Complaints regulations If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: https://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible. Abstract Objectives: To evaluate whether the application of heparin treated circuits for elective coronary artery surgery improves postoperative recovery, a European multicenter randomised clinical trial was carried out. Methods: In 11 European heart centers, 805 low-risk patients underwent cardiopulmonary bypass (CPB) with either an untreated circuit (n= 407) or an identical but heparin treated circuit (n= 398, Duraflo ® II). Results: Significant differences were found among participating centers with respect to patient characteristics, blood handling procedures and postoperative care. The use of heparin treated circuits revealed no overall changes in blood loss, blood use, time on ventilator, occurrence of adverse events, morbidity, mortality, and intensive care stay. These results did not change after adjustment for centers and (other) prognostic factors as analysed with logistic regression. In both groups no clinical or technical (patient or device related) side effects were reported. Because female gender and aortic * Corresponding author. The European Working Group on heparin coated extracorporeal circulation circuits, P.O. Box 169, 5400 AD Uden, Netherlands. Tel.: + 31 413 286621; fax +31 413 250085. 1010-7940/97/$17.00 © 1997 Elsevier Science B.V. All rights reserved. PII S 1 0 1 0 -7 9 4 0 ( 9 6 ) 0 1 1 2 2 -0 C. R.H. Wilde6uur et al. / European Journal of Cardio-thoracic Surgery 11 (1997) 616-623 C.R.H. Wilde6uur et al. / European Journal of Cardio-thoracic Surgery 11 (1997 cross clamp time appeared as prognostic factors in the logistic regression analysis, a subgroup analysis with these variables was performed. In a subpopulation of females (n= 99), those receiving heparin treated circuits needed less blood products, had a lower incidence of rhythm disturbances and were extubated earlier than controls. In another subgroup of patients with aortic cross clamp time exceeding 60 min (n=197), the amount of patients requiring prolonged intensive care treatment (\24 h) was significantly lower when they received heparin treated circuits versus controls. Conclusion: These findings suggest that improved recovery can be expected with heparin treated circuits in specific higher risk patient populations (e.g. females) and when prolonged aortic cross clamp time is anticipated. Further investigations are recommended to analyse the clinical benefit of heparin treated circuits in studies with patients in different well defined risk categories and under better standardised circumstances. © 1997 Elsevier Science B.V

The EU as an international security actor after Lisbon: finally a green light for a holistic approach?

This article argues that a holistic approach is important when studying the European Union’s (EU) role as an international security actor, but at the same time it identifies problems in adopting such a comprehensive research agenda. The holistic approach entails that the research must include ‘new’ security problems, such as climate change, but also relevant policies and instruments outside the framework of the Common Security and Defence Policy (CSDP). However, owing to conceptual, legal and political obstacles, this has been difficult to achieve; as a consequence, existing research on the EU as an international security actor tends to narrow down the focus to just one framework: the CSDP and its operations. This may lead to a distorted image, because the EU’s role in international security surpasses any single policy framework. The contribution of this article is twofold. First, it sets the framework for the comprehensive research agenda concerning the EU as an international security actor. Second, it identifies key obstacles that are making this holistic approach methodologically and conceptually difficult. In this context, the Lisbon Treaty, formally abandoning the pillar structure of the EU, provides an opportunity to mitigate at least some of these roadblocks