[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-graft-dysfunction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-graft-dysfunction":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,73,87,110,129],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100054072","prospective-reduction-of-transplant-complications-through-enhanced-preservation-therapy-to-prevent-primary-graft-dysfunction-100054072",false,"NCT07230886","Prospective Reduction Of Transplant Complications Through Enhanced Preservation Therapy to Prevent Primary Graft Dysfunction","PROTECT-PGD","Inclusion Criteria:\n\n* Recipient: Adult (\\>17 years old)\n* Donor: Donation after brain death acceptable for transplant as determined by a procuring physician unaware of randomization sequence at the time of acceptance\n\nExclusion Criteria:\n\n* Recipient: Multi-organ transplant recipients; Participating in an interventional study.\n* Donor: Donation after cardiac death; Use of organ care system","ALL","17 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to test the feasibility of the study protocol comparing a novel temperature control system - Xo Port Organ Preservation System - to static ice for heat preservation for Heart Transplant. The main questions of the study are as follows:\n\nDoes the Incidence of severe PGD change within the first 24 hours of heart transplant in patients randomized to the Xo Port Organ Preservation System?\n\nWas there a change in composite efficacy endpoints in participants randomized to the Xo Port Organ Preservation System compared to static ice storage?\n\nWere the feasibility outcomes achieved?\n\nWere there any protocol deviations?\n\nParticipants will:\n\nBe randomized to either the Xo Port Organ Preservation System or static ice storage.\n\nComplete a questionnaire at the time of screening, day 0, 7, and 90 days post transplant.\n\nHave blood drawn - with their standard of care blood draws - after their transplant, the day after, and 7 days post transplant.",[26],"Primary Graft Dysfunction",[26,28,29,30,31],"Transplant","Traferox","Preservation Therapy","X Port Preservation System","RECRUITING","2026-07-09",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":36},"2026-04-17",{"date":40,"type":20},"2028-12",{"name":42,"class":43},"University Health Network, Toronto","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":44},"100581662","phase-2-this-study-is-assessing-the-safety-and-efficacy-of-immune-inhibition-as-a-treatment-to-prevent-primary-graft-dysfunction-100581662","NCT06853223","This Study is Assessing the Safety and Efficacy of Immune Inhibition as a Treatment to Prevent Primary Graft Dysfunction","A Randomized Trial of CCR5 Inhibition as a Complement to Lung Transplant Induction Immunosuppression","MARAVIROC","Inclusion Criteria:\n\n1. Male or female ≥18 years of age at the time of lung transplant waitlisting.\n2. Listed for a bilateral lung transplantation.\n3. Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.\n4. PGD risk score \\> 50% at the time of donor organ offer\n5. Planned induction with basiliximab, mycophenolatge, and prednisone and routine maintenance immunosuppression of tacrolimus, mycophenolate and prednisone.\n\nExclusion Criteria:\n\n1. Recipient scheduled to receive alternate induction regimen that is cell depleting such as anti-thymocyte globulin or alemtuzumab.\n2. Active chronic pulmonary infection in the recipient that are considered relative contraindications to lung transplantation such as Burkholderia or Mycobacterium abscessus.\n3. Recipients receiving HIV, HCV or HBV positive donor organs. Only documented infections are considered exclusion criteria. Recipients receiving increased risk organs will not be excluded.\n4. Recipient listed for concurrent heart or other solid organ transplantation.\n5. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.",true,"18 Years",{"count":56,"type":20},120,[58],"PHASE2","Lung transplant recipient survival lags other solid organ recipients, with the main early cause of death being primary graft dysfunction (PGD). PGD occurs in up to 1\u002F3 of all recipients, is driven by the body's innate immune response, and has no known medical therapies for treatment or prevention. Investigators have recently shown that Natural Killer (NK) cells, a key innate immune cell, are critical in causing PGD. Importantly, the investigators found that Maraviroc, an FDA-approved drug that works to inhibit these immune cells, prevented lung injury in mouse models of PGD.\n\nThe goal of this clinical trial is to learn if Maraviroc works to treat PGD in Lung Transplant patients who are above the age of 18 and have a PGD risk score greater than 50%. The objectives the study hopes to address are:\n\nTo address the safety and tolerability of Maraviroc. To test a strategy for PGD enrichment in a lung transplant population. To measure the efficacy and biological efficacy of using Maraviroc. To study the biochemical, physiologic, and molecular effects of the drug on the body.\n\nThis will be a double blind study where patients will either get the Maraviroc drug or a placebo. Researchers will then compare the two groups to address the above objectives.\n\nParticipants will:\n\nTake drug Maraviroc or a placebo every 12 hours for 3 days post surgery. Follow up will occur during the entire length of stay at UCSF, about 16 days, with a single 12 month follow up once released.",[26,61,62,63],"Lung Transplantation","Acute Lung Injury(ALI)","Natural Killer Cell Mediated Immunity","2026-01-15",{"date":66,"type":36},"2026-01-20",{"date":68,"type":36},"2025-12-07",{"date":70,"type":20},"2028-08-14",{"name":72,"class":43},"University of California, San Francisco",{"id":74,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":24,"conditions":77,"keywords":78,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":86,"locationsCount":4},"100610692",{"count":19,"type":20},[23],[26],[26,28,29,30,31],"NOT_YET_RECRUITING","2025-11-13",{"date":82,"type":36},"2025-11-17",{"date":84,"type":20},"2025-11",{"date":40,"type":20},{"name":42,"class":43},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":44},"100099147","risk-factors-that-increase-the-chance-of-developing-primary-graft-dysfunction-after-lung-transplantation-100099147","NCT00552357","Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation","Clinical Risk Factors for Primary Graft Dysfunction","Inclusion Criteria:\n\n* Undergoing lung or combined heart and lung transplantation\n\nExclusion Criteria:\n\n* Undergoing combined organ transplantation other than heart and lung transplantation","13 Years","68 Years",{"count":97,"type":20},1150,"OBSERVATIONAL","Primary graft dysfunction (PGD) is a severe lung complication that can occur in the days after lung transplant surgery. This study will analyze blood samples to determine if high levels of certain chemicals may increase the risk of developing PGD after a lung transplant.",[26,61],"2025-07-11",{"date":103,"type":36},"2025-07-16",{"date":105,"type":4},"2007-12",{"date":107,"type":20},"2026-06",{"name":109,"class":43},"University of Pennsylvania",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":128,"locationsCount":44},"100092034","identifying-genetic-characteristics-that-increase-risk-of-primary-graft-dysfunction-following-lung-transplantation-100092034","NCT00457847","Identifying Genetic Characteristics That Increase Risk of Primary Graft Dysfunction Following Lung Transplantation","Genetics of Primary Graft Dysfunction","Inclusion Criteria:\n\n* Undergoing lung transplant surgery\n\nExclusion Criteria:\n\n\\- Individuals undergoing multi-organ transplantation except heart\u002Flung transplants","15 Years","65 Years",{"count":97,"type":20},"Primary graft dysfunction (PGD) is a severe lung injury that can occur in the days following lung transplant surgery. The purpose of this study is to identify genetic factors that may put someone at risk for developing PGD.",[26,61],[123],"PGD",{"date":103,"type":36},{"date":126,"type":4},"2007-02",{"date":107,"type":20},{"name":109,"class":43},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":44},"100468082","exhaled-breath-particles-in-lung-transplantation-100468082","NCT05375149","Exhaled Breath Particles in Lung Transplantation","Exhaled Breath Particles as a Clinical Indicator for Acute and Chronic Rejection After Lung Transplantation","Inclusion Criteria:\n\n* Patients who have undergone LTx at Skåne University Hospital, SUS Lund\n\nExclusion Criteria:\n\n* None","16 Years","75 Years",{"count":139,"type":20},150,"Lung transplantation (LTx) is the only effective treatment for patients with end stage lung disease. Of the major organs transplanted, survival following LTx is the lowest with a mean of 5 years. Despite improvements, primary graft dysfunction (PGD) remains the leading cause of early mortality and contributes to the development of chronic lung allograft dysfunction (CLAD) that remains the leading cause of late mortality. Earlier detection of rejection after LTx is of substantial importance as it would improve the possibilities of treatment and could increase survival.\n\nThe investigators have shown in previous work that exhaled breath particles (EBP) reflect the composition of respiratory tract lining fluid (RTLF). EBP and particle flow rate (PFR) can be used as non-invasive methods for early detection and monitoring of airway diseases such as acute respiratory distress syndrome (ARDS). It has also been shown that the particle flow prolife after lung transplantation differs between patients who develop PGD and those who do not and that the composition of EBP differs between patients with and without bronchiolitis obliterans syndrome (BOS), an obstructive form of CLAD.\n\nSamples of EBP and measurements of PFR will be collected from lung transplanted patients. Membranes with EBP will be saved for molecular analysis. The investigators aim to identify potential particle flow patterns and biomarkers for earlier detection of rejection after lung transplantation.",[142,26,143],"Lung Transplant Rejection","Chronic Rejection of Lung Transplant",[145,146,147,26,148],"Exhaled Breath Particles","PExA","Lung transplantation","Chronic Lug Allograft Dysfunction","2022-05-10",{"date":151,"type":36},"2022-05-16",{"date":153,"type":36},"2018-09-18",{"date":155,"type":20},"2026-09",{"name":157,"class":43},"Lund University Hospital"]