[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT00457847":3,"trial-entities:NCT00457847":69,"trial-summary:NCT00457847":72},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":30,"secondary_outcomes":35,"sex":36,"minimum_age":37,"maximum_age":38,"healthy_volunteers":39,"eligibility_criteria":40,"std_ages":45,"locations":49,"central_contacts":58,"overall_officials":59,"references":63,"see_also_links":68},"NCT00457847","1380","Identifying Genetic Characteristics That Increase Risk of Primary Graft Dysfunction Following Lung Transplantation","Genetics of Primary Graft Dysfunction","ACTIVE_NOT_RECRUITING","2027-06","2026-07","2026-07-22","2007-02","University of Pennsylvania","OTHER",true,"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.","PGD is a severe complication that affects up to 25% of lung transplant patients following surgery. Pulmonary edema, which is an abnormal build-up of fluid in the lungs, and hypoxemia, which is low blood oxygen levels, are two common symptoms that individuals with PGD experience. Treatment for this condition is often expensive, and it is the leading cause of death following lung transplant. Many potential donors and recipients are considered unsuitable for lung transplant because of concern for the development of PGD. Therefore, the ability to accurately predict which individuals are at risk for developing PGD may allow more lung transplants to be performed. Specific characteristics in both lung donors and recipients may play an important role in determining the risk of PGD. For example, genetic variations in how the body deals with harmful chemicals called oxidants may be associated with the development of PGD. The purpose of this study is to identify the specific genetic biomarkers in donors and recipients that put individuals at risk for developing PGD following a lung transplant.\n\nThis study will enroll individuals who are undergoing lung transplantation. Blood samples will be collected from lung donors and from participants prior to surgery, immediately following surgery, and 24 hours after surgery. Study researchers will monitor participants for 72 hours following surgery for symptoms of PGD. There will be no additional study visits.",[19,20],"Primary Graft Dysfunction","Lung Transplantation",[22],"PGD","OBSERVATIONAL",null,[],{"count":27,"type":28},1150,"ESTIMATED",[],[31],{"measure":32,"description":33,"timeFrame":34},"Primary graft dysfunction","ISHLT standard definition and grading system will be used","First 72 hours post lung transplantation",[],"ALL","15 Years","65 Years",false,{"inclusion":41,"exclusion":43,"raw_text":44},[42],"Undergoing lung transplant surgery",[],"Inclusion Criteria:\n\n* Undergoing lung transplant surgery\n\nExclusion Criteria:\n\n\\- Individuals undergoing multi-organ transplantation except heart\u002Flung transplants",[46,47,48],"CHILD","ADULT","OLDER_ADULT",[50],{"facility":13,"city":51,"state":52,"zip":53,"country":54,"geoPoint":55},"Philadelphia","Pennsylvania","19104","United States",{"lat":56,"lon":57},39.95238,-75.16362,[],[60],{"name":61,"affiliation":13,"role":62},"Jason D. Christie, MD","PRINCIPAL_INVESTIGATOR",[64],{"pmid":65,"type":66,"citation":67},"24467603","DERIVED","Diamond JM, Akimova T, Kazi A, Shah RJ, Cantu E, Feng R, Levine MH, Kawut SM, Meyer NJ, Lee JC, Hancock WW, Aplenc R, Ware LB, Palmer SM, Bhorade S, Lama VN, Weinacker A, Orens J, Wille K, Crespo M, Lederer DJ, Arcasoy S, Demissie E, Christie JD; Lung Transplant Outcomes Group. Genetic variation in the prostaglandin E2 pathway is associated with primary graft dysfunction. Am J Respir Crit Care Med. 2014 Mar 1;189(5):567-75. doi: 10.1164\u002Frccm.201307-1283OC.",[],{"nct_id":4,"conditions":70,"biomarkers":71},[20],[],{"nct_id":4,"found":15,"summary":73,"prompt_version":83},{"design":74,"status":75,"heading":76,"summary":77,"follow_up":78,"word_count":79,"commitments":80,"compensation":81,"drugs_mentioned":82},"This is an observational study planning to enroll 1150 participants. It is not a treatment study, but rather aims to identify genetic factors related to a complication after lung transplant.","completed","Identifying Genetic Risk for Primary Graft Dysfunction After Lung Transplant","This observational study aims to understand why some people develop primary graft dysfunction (PGD), a severe lung injury, after a lung transplant. PGD can cause fluid buildup in the lungs (pulmonary edema) and low blood oxygen (hypoxemia), and it's a major concern after surgery. Researchers want to find specific genetic characteristics in both lung donors and recipients that might increase the risk of PGD. By identifying these genetic factors, doctors might be able to predict who is most at risk, potentially allowing more people to receive life-saving lung transplants. You can join if you are between 15 and 65 years old and are having a lung transplant. The study will look at PGD within the first 72 hours after your transplant. The current recruitment status is unclear.","The primary outcome, primary graft dysfunction, is measured within the first 72 hours after lung transplantation.",127,"Blood samples will be collected from lung donors and from you before surgery, immediately after surgery, and 24 hours after surgery.","Not stated in the trial record.",[],"v2"]