[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525179":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":53,"collaborators":20,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":20,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":20,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":20,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"University of Virginia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment with recombinant vWF","EXPERIMENTAL","ECMO patients with major bleeding who are enrolled in the trial will receive treatment with recombinant von Willebrand Factor a single time. The dose will be 50 IU\u002Fkg and the drug will be given intravenously.",[13],"Drug: Recombinant von Willebrand Factor",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Recombinant von Willebrand Factor","Recombinant von Willebrand Factor is a drug that is currently FDA approved to treat patients with certain types of von Willebrand Disease. In the current trial it will be used to treat ECMO patients who have acquired von Willebrand syndrome.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Michael Mazzeffi, MD","UVA","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","434-924-9520","syy4wa@uvahealth.org",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Keita Ikeda, PhD","434-924-2283","KI2D@uvahealth.org",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"UVA Hospital","RECRUITING","Charlottesville","Virginia","22903","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-78.47668,38.02931,{"lat":48,"lon":47},[51,52],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},{"type":25,"investigatorFullName":23,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Professor of Anesthesiology","100525179","phase-1-recombinant-vwf-concentrate-and-ecmo-100525179",false,"NCT06118372","Recombinant vWF Concentrate and ECMO","Safety and Tolerability of Recombinant Von Willebrand Factor Concentrate in Adult ECMO Patients With Major Bleeding: A Phase I Study","Inclusion Criteria:\n\n1. Adult patients (18 years or greater)\n2. On extracorporeal membrane oxygenation\n3. Major bleeding defined by CTCAE class 3 or greater\n4. Off systemic anticoagulation for at least 4 hours\n\nExclusion Criteria:\n\n1. Platelet count less than 40 x 109\u002FL\n2. International normalized ratio\\> 2.0\n3. Fibrinogen less than 150 mg\u002FdL\n4. Current participation in another clinical trial (interventional)\n5. Heparin induced thrombocytopenia (active)\n6. Acute liver failure, as indicated by bilirubin \\>20 mg\u002FdL or new onset hepatic encephalopathy\n7. Patient or legally authorized representative unable to give informed consent\n8. Allergy to recombinant von Willebrand Factor or any component of the product based on prior exposure\n9. Of childbearing age and positive pregnancy test during the same hospital admission, a pregnancy test will be mandatory for all women of child-bearing age\n10. Known congenital or acquired thrombophilia\n11. History of deep venous thrombosis, pulmonary embolism, circuit thrombosis, disseminated intravascular coagulation (DIC), ischemic stroke, ST elevation myocardial infarction (STEMI), or arterial thrombosis in the last 3 months.\n12. History of hypersensitivity to vWF concentrate\n13. Known history of vWF antibodies","ALL","18 Years",{"count":65,"type":66},12,"ESTIMATED","INTERVENTIONAL",[69],"PHASE1","Adult patients on extracoporeal membrane oxygenation (ECMO) frequently experience bleeding, which is in part caused by acquired von Willebrand syndrome (vWS). Prior in vitro studies have shown that the addition of recombinant von Willebrand Factor (vWF) to ECMO patient blood samples, normalizes platelet adhesion and thrombus formation. This study is a phase I study, where adult ECMO patients with refractory bleeding will be treated with recombinant vWF a single time. The primary objectives are to evaluate the safety, tolerability, and pharmacokinetics of recombinant vWF in adult ECMO patients.",[72],"Bleeding Disorder","2026-02-02",{"date":75,"type":76},"2026-02-05","ACTUAL",{"date":78,"type":76},"2024-10-03",{"date":80,"type":66},"2027-02-28",{"name":5,"class":6},1]