[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622252":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":18,"locations":24,"responsibleParty":38,"collaborators":42,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":10,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":10,"enrollmentInfo":57,"targetDuration":10,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":68,"whyStopped":10,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Cohort 1",null,"Main Cohort of patients who fulfill Inclusion Criteria",{"label":13,"type":10,"description":14,"interventionNames":10},"Cohort 2","Patients who develop GVHD with any of the following characteristics and were not included in cohort 1\n\n1. Grade III-IV aGVHD, or SR-aGVHD of any grade, whichever occurs first\n2. Moderate to Severe cGVHD or SR-cGVHD of any grade, whichever occurs first",{"label":16,"type":10,"description":17,"interventionNames":10},"Cohort 3","Patients included in either cohort 1 or 2 who are diagnosed with TA-TMA and receive eculizumab",[19],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Manuel R Espinoza Gutarra, M.D.","CONTACT","205-975-2576","mgutarra@uabmc.edu",[25],{"facility":26,"status":10,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":10},"O'Neal Comprehensive Cancer Center at UAB","Birmingham","Alabama","35294","United States","US",{"type":33,"coordinates":34},"Point",[35,36],-86.80249,33.52066,{"lat":36,"lon":35},{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Manuel Ricardo Espinoza-Gutarra","Assistant Professor",[43,46],{"name":44,"class":45},"BMS Foundation","UNKNOWN",{"name":47,"class":45},"Viracor Eurofins","100622252","assessing-the-incidence-of-transplant-associated-thrombotic-microangiopathy-ta-tma-in-adult-patients-undergoing-allogeneic-stem-cell-transplant-sct-100622252",false,"NCT07381205","Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)","Prospective Evaluation of Transplant Associated Thrombotic Microangiopathy (TA-TMA) Markers in a High-risk Cohort of Adults Undergoing Allogeneic Stem Cell Transplantation (SCT)","Inclusion Criteria:\n\n* Inclusion Criteria\n\n  1. Adult male or female, age ≥18\n  2. Undergoing allogeneic SCT at UAB for any indication and any donor source.\n  3. For patients in cohort 1: Patients deemed high-risk for developing high-risk TA-TMA as stated by any of the following criteria\\*:\n\n     1. BMI \\> 35\\[42\\]\n     2. Mismatched donor (either Haploidentical or Mismatched Unrelated donor)\\[18, 29\\]\n     3. Non-Malignant Transplant Indication (Severe Aplastic Anemia or Sickle Cell Disease)\\[18, 43\\]\n     4. Acute Lymphoblastic Leukemia (any kind)\\[18, 31\\]\n     5. African American, Hispanic, Asian or Native American Ethnicity \\[44\\]\n     6. Myeloablative Conditioning Regimen\\[18\\]\n     7. Pre-Existing Renal Disease\\*\\* (defined as any of the following: 24 Hr Creatinine Clearance \\\u003C60, baseline serum creatinine \\> 1.2, 24 hr proteinuria \\>150mg or random spot urine Protein Creatinine ratio \\> 150mg\u002Fg)\\[20, 45\\]\n     8. TBI-containing conditioning regimen \\>400cGy \\[46\\]\n     9. Prior Autologous or Allogeneic SCT\\[45\\]\n\n        * \\*Some of these criteria have been adapted from pediatric literature due to a higher number of publications in that setting and in cases where the adult data is lacking or contradictory.\n        * \\*\\*Proteinuria thresholds are obtained from KDIGO guidelines and include moderate and severe levels of proteinuria\\[47\\].\n  4. Females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment.\n  5. For patients in cohort 2: Patients who develop GVHD with any of the following characteristics and were not included in cohort 1\n\n     1. Grade III-IV aGVHD, or SR-aGVHD of any grade, whichever occurs first\n     2. Moderate to Severe cGVHD or SR-cGVHD of any grade, whichever occurs first\n  6. For patients in cohort 3: Patients included in either cohort 1 or 2 who are diagnosed with TA-TMA and receive eculizumab\n\nExclusion Criteria:\n\n* Exclusion Criteria\n\n  1. Any other active malignancy requiring treatment or with expected survival ≤1 year.\n  2. Patients with psychiatric illness or social situations that would limit compliance with the study requirements.","ALL","18 Years",{"count":58,"type":59},85,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn about the incidence of Transplant Associated Thrombotich Microangiopathy (TA-TMA), which is a known but underreported complication of Allogeneic Stem Cell Transplant (SCT). The main question it aims to answer is:\n\nWhat is the incidence of TA-TMA in adults undergoing SCT? How does TA-TMA diagnosis impact survival and other outcomes? Patients undergoing SCT will be eligible for this study, which will consist of collection of biological samples and standard clinical follow up.",[63,64],"Transplant Associated Microangiopathy TAM","Transplant Complication",[66,67],"Transplant Associated Thrombotic Microangiopathy","Allogeneic Stem Cell Transplant","NOT_YET_RECRUITING","2026-03-09",{"date":71,"type":72},"2026-03-11","ACTUAL",{"date":74,"type":59},"2026-07-01",{"date":76,"type":59},"2028-10",{"name":40,"class":6},1]