[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576115":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":32,"responsibleParty":49,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":20,"enrollmentInfo":65,"targetDuration":20,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Hospices Civils de Lyon","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: low-volume continuous veno-venous haemodialysis with MEX-CD1 use","EXPERIMENTAL","Patients enrolled will benefit 3 consecutive cycle of low volume continuous veno-venous haemodialysis using MEX-CD1 treatment.",[13],"Device: Low-volume continuous veno-venous haemodialysis with MEX-CD1 use",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Low-volume continuous veno-venous haemodialysis with MEX-CD1 use","MEX-CD1 is a hyper-chelating colloidal solution that can be added to the dialysate to be used in low-volume continuous veno-venous hemodialysis. Intervention includes 3 low-volume continuous veno-venous hemodialysis for a duration of 3h20 each. For non-hospitalized patients, the treatment is performed on an outpatient basis.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Auguste DARGENT, MD, PhD","CONTACT","+33 478 862 0026","auguste.dargent@chu-lyon.fr",{"name":28,"role":24,"phone":29,"phoneExt":30,"email":31},"Bernard ALLAOUCHICHE, MD","04 78 86 23 42","+33","bernard.allaouchiche@chu-lyon.fr",[33,43],{"facility":34,"status":35,"city":36,"state":20,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":20,"geoPoint":20,"contacts":40},"Hôpital Lyon Sud","RECRUITING","Oullins-Pierre-Bénite","69495","France","FR",[41],{"name":23,"role":24,"phone":42,"phoneExt":20,"email":26},"+33 478 862 006",{"facility":34,"status":35,"city":36,"state":20,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":20,"geoPoint":20,"contacts":44},[45],{"name":46,"role":24,"phone":47,"phoneExt":20,"email":48},"Maël HEIBLIG, MD, PhD","+33 478 862 210","mael.heiblig@chu-lyon.fr",{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[52],{"name":53,"class":54},"MEXBrain 13 avenue Albert Einstein 69100 Villeurbanne","UNKNOWN","100576115","feasibility-trial-of-extracorporeal-iron-purification-in-patients-with-myelodysplastic-syndrome-or-myelofibrosis-100576115",false,"NCT06781099","Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis","Feasibility, Tolerability and Efficacy of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis Intolerant of or Contraindicated to Oral or Subcutaneous Chelation Treatment.","MEXIRON","Inclusion Criteria:\n\n* Patient followed for myelodysplastic syndrome or myelofibrosis.\n* Patient with platelet count ≥50 giga\u002FL at inclusion.\n* Patients with severe anemia and hemoglobin \\\u003C70 g\u002FL at baseline.\n* Patient with intolerance or contraindication to oral or subcutaneous chelation therapy.\n* Ferritinemia \\>1000 µg\u002FL or hepatic iron concentration ≥7 mg\u002Fg or cardiac T2\\* \\\u003C20 ms at inclusion.\n* Patient able to understand (French-speaking) and comply with protocol, having signed informed consent.\n\nExclusion Criteria:\n\n* Patients with primary hemochromatosis (transferrin saturation coefficient CS-Tf \\> 45%).\n* Patients with a contraindication to the use of MEX-CD1: weight \\\u003C 30 kg, iron deficiency.\n* Patients with a known allergy or contraindication to heparin or citrate.\n* Patients undergoing azacitidine or other chemotherapy (or considered as such) for myelodysplastic syndrome or myelofibrosis.\n* Patient who received treatment with luspatercept or erythropoietin (EPO) during the month prior to inclusion.\n* Patients with indications for allogeneic bone marrow transplantation.\n* Patients with a known allergy to shellfish (MEX-CD1 contains chitosan of animal origin) or to one of the other components of MEX-CD1.\n* Patients with a peripheral vascular access that is difficult to access or that needs to be preserved.\n* Patients participating in other interventional research that could interfere with the results of the study.\n* Patients under legal protection or unable to express their consent.\n* Patients under psychiatric care.\n* Patient deprived of liberty by judicial or administrative decision.\n* Pregnant or breast-feeding women.","ALL","18 Years",{"count":66,"type":67},13,"ESTIMATED","INTERVENTIONAL",[70],"NA","In transfusion-dependent myelodysplastic syndromes patients, regular blood transfusions lead to iron overload, which can cause organ damage, hormonal imbalances, and increased infection risk, ultimately impacting patient survival. Standard oral iron chelation therapies can be intolerable for some patients due to adverse effects. The MEX-CD1 device (class III) could potentially offer an alternative for these patients by reducing serum iron levels through a novel, extracorporeal approach.\n\nMEXIRON clinical investigation focuses on the use of MEX-CD1, a medical device designed for extracorporeal chelation therapy to reduce iron overload in patients suffering from transfusion-dependent myelodysplastic syndromes (MDS) and myelofibrosis.\n\nMEXIRON aims to evaluate the device's use feasibility, safety, and effectiveness in reducing iron levels. Transfusions needs, patient experience and quality of life are also assessed.\n\nEach enrolled patients will undergo three low-volume continuous veno-venous haemodialysis cycles within one week.\n\nFollowing the three- haemodialysis cycles, patients will be monitored through on-site follow-up visits at 7 days, 28 days, and 90 days post-treatment to assess long-term effects.",[73,74],"Myelodysplastic Syndrome","Myelofibrosis",[76,77,78,79],"Myelodysplastic syndrome","myelofibrosis","iron chelation therapy","haemodialysis","2026-04-22",{"date":82,"type":83},"2026-04-23","ACTUAL",{"date":85,"type":83},"2026-01-06",{"date":87,"type":67},"2027-05-06",{"name":5,"class":6},2]