{"id":3639,"date":"2020-10-16T13:32:33","date_gmt":"2020-10-16T11:32:33","guid":{"rendered":"https:\/\/aa-pnh.pe-dev.de\/emaa-trial\/"},"modified":"2021-12-08T10:30:10","modified_gmt":"2021-12-08T09:30:10","slug":"emaa-trial","status":"publish","type":"post","link":"https:\/\/aa-pnh.org\/en\/emaa-trial\/","title":{"rendered":"EMAA trial"},"content":{"rendered":"<p><img decoding=\"async\" src=\"https:\/\/aa-pnh.org\/wp-content\/uploads\/2020\/10\/EMAA-title-e1603021809799.gif\" alt=\"EMAA trail for patients with moderate Aplastic Anaemia\"\/><\/p>\n<p><strong>Adult patients with acquired moderate Aplastic <a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;Anaemia&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Reduction of red blood cells or their content of (blood pigment); as a result of blood loss, reduced haemoglobin production, reduced blood cell development due to bone marrow diseases, increased blood cell decay due to poisoning and metabolic disorders. Anaemia leads to reduced physical capacity. &lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/anaemia\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">Anaemia<\/a> (mAA)<\/strong> <strong>who have not received a specific treatment for their mAA<\/strong> may be included in the EMAA trial of Ulm University (<strong>E<\/strong>ltrombopag in <strong>M<\/strong>oderate <strong>A<\/strong>plastic <strong>A<\/strong>naemia). They receive either <a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;ciclosporin&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Also known as cyclosporin A, CsA; immunosuppressive medication administered e.g. to treat aplastic anaemia and prevent GvHD disease. In high doses and with long-term administration, its main side effects are hypertension, tremor of the hands and deterioration of kidney function. Blood levels(...)&lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/ciclosporin\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">ciclosporin<\/a> and eltrombopag or <a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;ciclosporin&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Also known as cyclosporin A, CsA; immunosuppressive medication administered e.g. to treat aplastic anaemia and prevent GvHD disease. In high doses and with long-term administration, its main side effects are hypertension, tremor of the hands and deterioration of kidney function. Blood levels(...)&lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/ciclosporin\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">ciclosporin<\/a> and a placebo. The aim of the trial is to evaluate the efficacy and safety of the combination therapy of <a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;ciclosporin&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Also known as cyclosporin A, CsA; immunosuppressive medication administered e.g. to treat aplastic anaemia and prevent GvHD disease. In high doses and with long-term administration, its main side effects are hypertension, tremor of the hands and deterioration of kidney function. Blood levels(...)&lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/ciclosporin\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">ciclosporin<\/a> and eltrombopag. Patients with or without prior <a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;transfusion&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Transfer of blood or blood components&lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/transfusion\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">transfusion<\/a>s can be included.<\/p>\n<h5><!--more--><\/h5>\n<p>A <strong>moderate Aplastic <a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;Anaemia&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Reduction of red blood cells or their content of (blood pigment); as a result of blood loss, reduced haemoglobin production, reduced blood cell development due to bone marrow diseases, increased blood cell decay due to poisoning and metabolic disorders. Anaemia leads to reduced physical capacity. &lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/anaemia\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">Anaemia<\/a><\/strong> is defined as the bone marrow containing not enough cells and any two of the following criteria are fulfilled:<\/p>\n<p><a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;neutrophils&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Subgroup of granulocytes with an important role in defending against bacterial and fungal infections&lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/neutrophils\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">neutrophils<\/a> (ANC) less than 1.2 G\/l<br>\n<a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;reticulocyte&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Young, immature red blood cell; precursor of erythrocyte&lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/reticulocyte\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">reticulocyte<\/a>s (immature red blood cells) less than 60 G\/l<br>\n<a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;thrombocytes&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Smallest form of blood cells, whose main task is to maintain blood clotting&lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/thrombocytes\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">thrombocytes<\/a> (platelets, PLT) less than 70 G\/l<br>\nsignificant symptoms<br>\n<br>\n<strong>inclusion criteria<\/strong><\/p>\n<p><strong>if not transfuion dependent<\/strong>: (at least one criterion)<br>\n<a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;neutrophils&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Subgroup of granulocytes with an important role in defending against bacterial and fungal infections&lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/neutrophils\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">neutrophils<\/a> (ANC) less than 1.0 G\/l<br>\n<a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;haemoglobin&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Hb; red blood cell pigment consisting of haem (an iron-containing component) and globin (a protein). Binds, transports and releases oxygen and carbon dioxide. Reference values: women 12-16 g\/dl or 7.5-9.9 mmol\/l, men 14-18 g\/dl or 8.7-11.2 mmol\/l &lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/haemoglobin\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">haemoglobin<\/a> (HGB, Hb) &lt; 8.5 g\/dl or ca. 5,28 mmol\/L<br>\nthrombozytes (platelets, PLT) &lt; 30 G\/l<br>\nsignificant symptoms<\/p>\n<p><strong>if <a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;transfusion&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Transfer of blood or blood components&lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/transfusion\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">transfusion<\/a> dependent<\/strong>: (at least one criterion)<br>\nmore than 4 PRBCs in 12 weeks (PRBC = Packed Red Blood Cells)<br>\nplatelet <a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;transfusion&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Transfer of blood or blood components&lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/transfusion\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">transfusion<\/a> for therapeutic reasons in case of bleeding\/signs of bleeding<br>\n<a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;prophylactic&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Prevention or precaution&lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/prophylactic\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">prophylactic<\/a> platelet <a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;transfusion&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Transfer of blood or blood components&lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/transfusion\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">transfusion<\/a> when platelets are less than 10 G\/l<\/p>\n<p>trial sites:<br>\nAachen, Basel, Berlin, Chemnitz, Essen, Hamburg, Hanover, Ulm<\/p>\n<p>The independent Data Safety Monitoring Board recently evaluated the risk-benefit ratio and recommends the continuation of the trial.<\/p>\n<p><strong>Furhter information<\/strong> is in the<a href=\"https:\/\/aa-pnh.org\/wp-content\/uploads\/2020\/12\/Flyer-EMAA-Studie.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">trial folder<\/a>. If you have any questions please email Dr Britta H&ouml;chsmann at <a href=\"mailto:b.hoechsmann@blutspende.de\" target=\"_blank\" rel=\"noopener noreferrer\">b.hoechsmann(at)blutspende.de<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Adult patients with acquired moderate Aplastic <a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;Anaemia&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Reduction of red blood cells or their content of (blood pigment); as a result of blood loss, reduced haemoglobin production, reduced blood cell development due to bone marrow diseases, increased blood cell decay due to poisoning and metabolic disorders. Anaemia leads to reduced physical capacity. &lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/anaemia\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">Anaemia<\/a> (mAA) who have not received a specific treatment for their mAA may be included in the EMAA trial of Ulm University (Eltrombopag in Moderate Aplastic <a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;Anaemia&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Reduction of red blood cells or their content of (blood pigment); as a result of blood loss, reduced haemoglobin production, reduced blood cell development due to bone marrow diseases, increased blood cell decay due to poisoning and metabolic disorders. Anaemia leads to reduced physical capacity. &lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/anaemia\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">Anaemia<\/a>). They receive either <a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;ciclosporin&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Also known as cyclosporin A, CsA; immunosuppressive medication administered e.g. to treat aplastic anaemia and prevent GvHD disease. In high doses and with long-term administration, its main side effects are hypertension, tremor of the hands and deterioration of kidney function. Blood levels(...)&lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/ciclosporin\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">ciclosporin<\/a> and eltrombopag or <a class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;ciclosporin&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;Also known as cyclosporin A, CsA; immunosuppressive medication administered e.g. to treat aplastic anaemia and prevent GvHD disease. In high doses and with long-term administration, its main side effects are hypertension, tremor of the hands and deterioration of kidney function. Blood levels(...)&lt;\/div&gt;\" href=\"https:\/\/aa-pnh.org\/en\/glossar\/ciclosporin\/\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]' tabindex=\"0\" role=\"link\">ciclosporin<\/a> and a placebo. The&hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"gallery","meta":{"footnotes":""},"categories":[81,80],"tags":[84,83],"class_list":["post-3639","post","type-post","status-publish","format-gallery","hentry","category-medication","category-studies","tag-medication","tag-studies","post_format-post-format-gallery"],"_links":{"self":[{"href":"https:\/\/aa-pnh.org\/en\/wp-json\/wp\/v2\/posts\/3639","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/aa-pnh.org\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/aa-pnh.org\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/aa-pnh.org\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/aa-pnh.org\/en\/wp-json\/wp\/v2\/comments?post=3639"}],"version-history":[{"count":0,"href":"https:\/\/aa-pnh.org\/en\/wp-json\/wp\/v2\/posts\/3639\/revisions"}],"wp:attachment":[{"href":"https:\/\/aa-pnh.org\/en\/wp-json\/wp\/v2\/media?parent=3639"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/aa-pnh.org\/en\/wp-json\/wp\/v2\/categories?post=3639"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/aa-pnh.org\/en\/wp-json\/wp\/v2\/tags?post=3639"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}