{"id":46,"date":"2020-05-07T22:30:29","date_gmt":"2020-05-08T02:30:29","guid":{"rendered":"https:\/\/dnable.wpengine.com\/ct\/?page_id=46"},"modified":"2021-06-10T09:30:16","modified_gmt":"2021-06-10T13:30:16","slug":"opo-faqs","status":"publish","type":"page","link":"\/clinicaltrial-03641677\/resources\/opo-faqs\/","title":{"rendered":"OPO Clinical Trial FAQs"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"46\" class=\"elementor elementor-46\" data-elementor-settings=\"[]\">\n\t\t\t\t\t\t<div class=\"elementor-inner\">\n\t\t\t\t\t\t\t<div class=\"elementor-section-wrap\">\n\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5f1ada3 el-section-grid no-vertical elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5f1ada3\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t\t\t<div class=\"elementor-row\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-76f66af\" data-id=\"76f66af\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b2de993 elementor-widget elementor-widget-lbe-faq\" data-id=\"b2de993\" data-element_type=\"widget\" data-widget_type=\"lbe-faq.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"c-faq\">\n\t\t\t<div class=\"c-faq__nav c-faq__question\"><ul><li><a href=\"#faq-a00f9bc\"><span>Is there a reference that needs to be followed for procuring the lungs for this study?<\/span><\/a><\/li><li><a href=\"#faq-368d470\"><span>Who is responsible for transportation arrangements to and from LBE facilities?<\/span><\/a><\/li><li><a href=\"#faq-5d6918d\"><span>How should the lungs be packaged for transport to LBE facilities?<\/span><\/a><\/li><li><a href=\"#faq-22d5ec5\"><span>Is research authorization required for donor lungs in your clinical trial?<\/span><\/a><\/li><li><a href=\"#faq-71e4662\"><span>Will the OPO receive updates on lungs sent for EVLP?<\/span><\/a><\/li><li><a href=\"#faq-501cc6e\"><span>Can donor lungs be allocated to two different centers?<\/span><\/a><\/li><li><a href=\"#faq-2d209d9\"><span>What happens when EVLP is complete and the requesting transplant center declines the lung(s)?<\/span><\/a><\/li><\/ul><\/div><div class=\"c-faq__content\"><div id=\"faq-a00f9bc\" class=\"c-faq__item c-faq__item-a00f9bc \"><div class=\"c-faq__columns\"><div class=\"c-faq__left-col\"><div class=\"c-faq__question\"><h4 class=\"c-faq__question-heading\">Is there a reference that needs to be followed for procuring the lungs for this study?<\/h4><\/div><div class=\"c-faq__answer\"><p>There are no protocol requirements for to the way that the lungs are procured. However, we do have a <a href=\"\/clinicaltrial-03641677\/wp-content\/uploads\/sites\/3\/2020\/06\/Technique-of-Lung-Retrieval-and-Preservation-for-EVLP_MOA-Appendix-A_Final-12Dec2016.pdf\" target=\"_blank\" rel=\"noopener\">\u201cLung Retrieval and Preservation for EVLP\u201d<\/a> reference that has recommendations for lung retrieval specifically for EVLP.<\/p><p>\u2022 Long pulmonary artery<\/p><p>\u2022 Large left atrial cuff<\/p><p>\u2022 Long trachea<\/p><p>It is recommended to review and share with your colleagues who perform the lung retrieval.<\/p><\/div><\/div><div class=\"c-faq__right-col\"><div class=\"c-faq__answer\">\n\t\t\t\t\t\t\t<p><a href=\"\/clinicaltrial-03641677\/wp-content\/uploads\/sites\/3\/2020\/06\/Technique-of-Lung-Retrieval-and-Preservation-for-EVLP_MOA-Appendix-A_Final-12Dec2016.pdf\" target=\"_blank\" rel=\"noopener\"><img loading=\"lazy\" class=\"wp-image-408 aligncenter\" src=\"\/clinicaltrial-03641677\/wp-content\/uploads\/sites\/3\/2020\/05\/icon_object_download-pdf-1.svg\" alt=\"\" width=\"157\" height=\"159\" \/><\/a><\/p><p><a href=\"\/clinicaltrial-03641677\/wp-content\/uploads\/sites\/3\/2020\/06\/Technique-of-Lung-Retrieval-and-Preservation-for-EVLP_MOA-Appendix-A_Final-12Dec2016.pdf\" target=\"_blank\" rel=\"noopener\"><strong>Lung Retrieval and Preservation for EVLP<\/strong><\/a><\/p><a href=\"\/clinicaltrial-03641677\/wp-content\/uploads\/sites\/3\/2020\/06\/Technique-of-Lung-Retrieval-and-Preservation-for-EVLP_MOA-Appendix-A_Final-12Dec2016.pdf\" target=\"_blank\" rel=\"nofollow\" class=\"button\">Download<\/a><\/div><\/div><\/div><\/div><div id=\"faq-368d470\" class=\"c-faq__item c-faq__item-368d470 \"><div class=\"c-faq__columns\"><div class=\"c-faq__left-col\"><div class=\"c-faq__question\"><h4 class=\"c-faq__question-heading\">Who is responsible for transportation arrangements to and from LBE facilities?<\/h4><\/div><div class=\"c-faq__answer\"><p>The transplant center and\/or OPO is responsible for local ground transportation at LBE. If for whatever reason transportation arrangements cannot be made expeditiously, Lung Bioengineering is able to assist in air and ground transportation logistics. All transportation costs are covered by LBE. The EVLP Specialist will be in contact with the coordinator at all times to ensure that lungs destined for LBE facilities get there as quickly as possible no matter who made the arrangements.<\/p><\/div><\/div><div class=\"c-faq__right-col\"><div class=\"c-faq__answer\">\n\t\t\t\t\t\t\t<p><img loading=\"lazy\" class=\"alignnone  wp-image-414\" src=\"\/clinicaltrial-03641677\/wp-content\/uploads\/sites\/3\/2020\/05\/icon_object_air-transportation.svg\" alt=\"\" width=\"276\" height=\"276\" \/><\/p><p><img loading=\"lazy\" class=\"alignnone  wp-image-416\" src=\"\/clinicaltrial-03641677\/wp-content\/uploads\/sites\/3\/2020\/05\/icon_object_transportation.svg\" alt=\"\" width=\"116\" height=\"116\" \/><\/p><\/div><\/div><\/div><\/div><div id=\"faq-5d6918d\" class=\"c-faq__item c-faq__item-5d6918d \"><div class=\"c-faq__columns\"><div class=\"c-faq__left-col\"><div class=\"c-faq__question\"><h4 class=\"c-faq__question-heading\">How should the lungs be packaged for transport to LBE facilities?<\/h4><\/div><div class=\"c-faq__answer\"><p>Lungs should be packaged according to OPTN policy for unaccompanied organs and include tissue typing material and blood.<\/p><p>To purchase insulated containers for shipping, please visit <a href=\"https:\/\/www.fishersci.com\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fishersci.com\/<\/a> (item number is SG-9W)<\/p><p>The OPTN policy can be accessed at the following address: <a href=\"https:\/\/optn.transplant.hrsa.gov\/media\/1200\/optn_policies.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/optn.transplant.hrsa.gov\/media\/1200\/optn_policies.pdf<\/a><\/p><\/div><\/div><div class=\"c-faq__right-col\"><div class=\"c-faq__answer\">\n\t\t\t\t\t\t\t<p><strong>INSULATED CONTAINERS FOR SHIPPING<\/strong><\/p><p>(Safe Guard Technologies INSULTED FORM CONTAINER\/WAX 4)<\/p><p>\u00a0<\/p><p class=\"p1\"><a class=\"button\" style=\"font-size: 16px\" href=\"http:\/\/www.fishersci.com\" target=\"_blank\" rel=\"noopener\">fishersci.com<\/a><\/p><p>\u00a0<\/p><p><strong>OPTN POLICY<\/strong><\/p><a href=\"\/clinicaltrial-03641677\/wp-content\/uploads\/sites\/3\/2020\/06\/optn_policies.pdf\" target=\"_blank\" rel=\"nofollow\" class=\"button\">Download<\/a><\/div><\/div><\/div><\/div><div id=\"faq-22d5ec5\" class=\"c-faq__item c-faq__item-22d5ec5 \"><div class=\"c-faq__columns\"><div class=\"c-faq__left-col\"><div class=\"c-faq__question\"><h4 class=\"c-faq__question-heading\">Is research authorization required for donor lungs in your clinical trial?<\/h4><\/div><div class=\"c-faq__answer\"><p>Our protocol requires authorization\/consent for research and transplantation as specified in each state\u2019s Uniform Anatomical Gift Law.<\/p><\/div><\/div><div class=\"c-faq__right-col\"><div class=\"c-faq__answer\">\n\t\t\t\t\t\t\t<p><img loading=\"lazy\" class=\"alignnone wp-image-419 \" src=\"\/clinicaltrial-03641677\/wp-content\/uploads\/sites\/3\/2020\/05\/icon_object_consent.svg\" alt=\"\" width=\"170\" height=\"170\" \/><\/p><\/div><\/div><\/div><\/div><div id=\"faq-71e4662\" class=\"c-faq__item c-faq__item-71e4662 \"><div class=\"c-faq__columns\"><div class=\"c-faq__left-col\"><div class=\"c-faq__question\"><h4 class=\"c-faq__question-heading\">Will the OPO receive updates on lungs sent for EVLP?<\/h4><\/div><div class=\"c-faq__answer\"><p>At the conclusion of the EVLP procedure, the study center must indicate the disposition of the lung (transplant or not transplant) in the client portal of the CMX. The OPO is then notified by Lung Bioengineering staff of the transplant center disposition.<\/p><\/div><\/div><div class=\"c-faq__right-col\"><div class=\"c-faq__answer\">\n\t\t\t\t\t\t\t<p><img loading=\"lazy\" class=\"wp-image-436 aligncenter\" src=\"\/clinicaltrial-03641677\/wp-content\/uploads\/sites\/3\/2020\/05\/alert-received.svg\" alt=\"\" width=\"255\" height=\"224\" \/><\/p><\/div><\/div><\/div><\/div><div id=\"faq-501cc6e\" class=\"c-faq__item c-faq__item-501cc6e \"><div class=\"c-faq__columns\"><div class=\"c-faq__left-col\"><div class=\"c-faq__question\"><h4 class=\"c-faq__question-heading\">Can donor lungs be allocated to two different centers?<\/h4><\/div><div class=\"c-faq__answer\"><p>Yes. It is possible for two lungs from a single donor to be sent for EVLP en bloc at LBE facilities, separated and sent to intended recipients at two different clinical trial sites.<\/p><\/div><\/div><div class=\"c-faq__right-col\"><div class=\"c-faq__answer\">\n\t\t\t\t\t\t\t<p><a href=\"\/clinicaltrial-03641677\/wp-content\/uploads\/sites\/3\/2020\/06\/two-centers-allocation-infographic.svg\"><img class=\"alignnone size-full wp-image-473\" src=\"\/clinicaltrial-03641677\/wp-content\/uploads\/sites\/3\/2020\/06\/two-centers-allocation-infographic.svg\" alt=\"\" \/><\/a><\/p><\/div><\/div><\/div><\/div><div id=\"faq-2d209d9\" class=\"c-faq__item c-faq__item-2d209d9 \"><div class=\"c-faq__columns\"><div class=\"c-faq__left-col\"><div class=\"c-faq__question\"><h4 class=\"c-faq__question-heading\">What happens when EVLP is complete and the requesting transplant center declines the lung(s)?<\/h4><\/div><div class=\"c-faq__answer\"><p>If EVLP demonstrates that the lung(s) are suitable for transplantation and the requesting center declines them, the host OPO will be notified. There are circumstances when the OPO will have the option to place the lungs with another program participating in the EVLP study. All allocation is to be completed by the host OPO. Lungs that are not approved for transplant are referred back to the organ procurement organization for final disposition.<\/p><\/div><\/div><div class=\"c-faq__right-col c-faq__right-col--no-content\"><div class=\"c-faq__answer\">\n\t\t\t\t\t\t\t<\/div><\/div><\/div><\/div><\/div>\t\t<\/div>\n\t\t\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Is there a reference that needs to be followed for procuring the lungs for this study? Who is responsible for transportation arrangements to and from LBE facilities? How should the lungs be packaged for transport to LBE facilities? Is research authorization required for donor lungs in your clinical trial? Will the OPO receive updates on [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":44,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_mi_skip_tracking":false},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v14.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Lung Bioengineering | OPO Clinical Trial FAQs<\/title>\n<meta name=\"description\" content=\"Useful information about Lung Bioengineering for organ procurement organizations\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"\/clinicaltrial-03641677\/resources\/opo-faqs\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Lung Bioengineering | OPO Clinical Trial FAQs\" \/>\n<meta property=\"og:description\" content=\"Useful information about Lung Bioengineering for organ procurement organizations\" \/>\n<meta property=\"og:url\" content=\"\/clinicaltrial-03641677\/resources\/opo-faqs\/\" \/>\n<meta property=\"og:site_name\" content=\"EVP-DEV-LTX-301\" \/>\n<meta property=\"article:modified_time\" content=\"2021-06-10T13:30:16+00:00\" \/>\n<meta property=\"og:image\" content=\"\/clinicaltrial-03641677\/wp-content\/uploads\/sites\/3\/2020\/05\/icon_object_download-pdf-1.svg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Organization\",\"@id\":\"\/clinicaltrial-03641677\/#organization\",\"name\":\"Lung Bioengineering\",\"url\":\"\/clinicaltrial-03641677\/\",\"sameAs\":[],\"logo\":{\"@type\":\"ImageObject\",\"@id\":\"\/clinicaltrial-03641677\/#logo\",\"inLanguage\":\"en-US\",\"url\":\"\/clinicaltrial-03641677\/wp-content\/uploads\/sites\/3\/2020\/05\/LBE_logo_brand-colors.png\",\"width\":330,\"height\":86,\"caption\":\"Lung Bioengineering\"},\"image\":{\"@id\":\"\/clinicaltrial-03641677\/#logo\"}},{\"@type\":\"WebSite\",\"@id\":\"\/clinicaltrial-03641677\/#website\",\"url\":\"\/clinicaltrial-03641677\/\",\"name\":\"Lung Bioengineering CLES Clinical Trial\",\"description\":\"Lung Bioengineering is conducting a clinical trial dedicated to ex vivo lung perfusion as part of our commitment to expanding the supply of available lungs.\",\"publisher\":{\"@id\":\"\/clinicaltrial-03641677\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":\"\/clinicaltrial-03641677\/?s={search_term_string}\",\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"ImageObject\",\"@id\":\"\/clinicaltrial-03641677\/resources\/opo-faqs\/#primaryimage\",\"inLanguage\":\"en-US\",\"url\":\"\/clinicaltrial-03641677\/wp-content\/uploads\/sites\/3\/2020\/05\/icon_object_download-pdf-1.svg\"},{\"@type\":\"WebPage\",\"@id\":\"\/clinicaltrial-03641677\/resources\/opo-faqs\/#webpage\",\"url\":\"\/clinicaltrial-03641677\/resources\/opo-faqs\/\",\"name\":\"Lung Bioengineering | OPO Clinical Trial FAQs\",\"isPartOf\":{\"@id\":\"\/clinicaltrial-03641677\/#website\"},\"primaryImageOfPage\":{\"@id\":\"\/clinicaltrial-03641677\/resources\/opo-faqs\/#primaryimage\"},\"datePublished\":\"2020-05-08T02:30:29+00:00\",\"dateModified\":\"2021-06-10T13:30:16+00:00\",\"description\":\"Useful information about Lung Bioengineering for organ procurement organizations\",\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"\/clinicaltrial-03641677\/resources\/opo-faqs\/\"]}]}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","_links":{"self":[{"href":"\/clinicaltrial-03641677\/wp-json\/wp\/v2\/pages\/46"}],"collection":[{"href":"\/clinicaltrial-03641677\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"\/clinicaltrial-03641677\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"\/clinicaltrial-03641677\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"\/clinicaltrial-03641677\/wp-json\/wp\/v2\/comments?post=46"}],"version-history":[{"count":1,"href":"\/clinicaltrial-03641677\/wp-json\/wp\/v2\/pages\/46\/revisions"}],"predecessor-version":[{"id":556,"href":"\/clinicaltrial-03641677\/wp-json\/wp\/v2\/pages\/46\/revisions\/556"}],"up":[{"embeddable":true,"href":"\/clinicaltrial-03641677\/wp-json\/wp\/v2\/pages\/44"}],"wp:attachment":[{"href":"\/clinicaltrial-03641677\/wp-json\/wp\/v2\/media?parent=46"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}