[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481338":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":98,"collaborators":25,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":25,"eligibilityCriteria":107,"healthyVolunteers":103,"sex":108,"minAge":109,"maxAge":25,"enrollmentInfo":110,"targetDuration":25,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Off-Pump Bilateral Lung Transplantation","ACTIVE_COMPARATOR","Subjects will receive 'off-pump' technique for lung transplantation as part of standard of care",[13],"Procedure: Off-pump lung transplantation",{"label":15,"type":10,"description":16,"interventionNames":17},"Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung Transplantation","Subjects will receive VA ECMO technique for lung transplantation as part of standard of care",[18],"Procedure: Venoarterial ECMO lung transplantation",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Off-pump lung transplantation","General anesthesia, intubation with double lumen tube, thoracotomies or clamshell incision, pneumonectomy starting by the less perfused lung in the scan, stump preparation, lung implantation, reperfusion, gradual release of the pulmonary artery clamp, deairing, ventilation of the 1st implanted lung. The process is repeated at the contralateral side. Ventilation of both lungs, chest closure.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Venoarterial ECMO lung transplantation","General anesthesia, intubation with double lumen tube, thoracotomies or clamshell incision, heparin, peripheral or central venoarterial ECMO cannulation, first pneumonectomy, stump preparation, lung implantation, reperfusion, release of the pulmonary artery clamp, deairing, ventilation of the 1st implanted lung. The process is repeated at the contralateral side. Ventilation of both lungs, ECMO decannulation, chest closure.",[15],[31],{"name":32,"affiliation":5,"role":33},"Mauricio Villavicencio, MD, MBA","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","507-2557068","villavicencio.mauricio@mayo.edu",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Jackie Reiter","507-538-2224","reiter.jacqulyn@mayo.edu",[44,62,81],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"University Of Louisville","RECRUITING","Louisville","Kentucky","40202","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-85.75941,38.25424,{"lat":56,"lon":55},[59],{"name":60,"role":36,"phone":61,"phoneExt":25,"email":25},"Matthew Fox, Dr.","502-587-4384",{"facility":63,"status":46,"city":64,"state":65,"zip":66,"country":50,"countryCode":51,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Mayo Clinic Rochester","Rochester","Minnesota","55905",{"type":53,"coordinates":68},[69,70],-92.4699,44.02163,{"lat":70,"lon":69},[73,76,78],{"name":74,"role":36,"phone":75,"phoneExt":25,"email":38},"Mauricio Villavicencio Theoduloz, MD, MBA","507-255-7068",{"name":77,"role":36,"phone":41,"phoneExt":25,"email":42},"Jacqulyn R Reiter",{"name":79,"role":80,"phone":25,"phoneExt":25,"email":25},"Suraj Yalamuri, MD","SUB_INVESTIGATOR",{"facility":82,"status":46,"city":83,"state":84,"zip":85,"country":50,"countryCode":51,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Baylor College of Medicine","Houston","Texas","77030",{"type":53,"coordinates":87},[88,89],-95.36327,29.76328,{"lat":89,"lon":88},[92,96],{"name":93,"role":36,"phone":94,"phoneExt":25,"email":95},"Gabriel Loor, MD","832-355-3000","gabriel.loor@bcm.edu",{"name":97,"role":33,"phone":25,"phoneExt":25,"email":25},"Gabriel Loor",{"type":33,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Mauricio A. Villavicencio Theoduloz","Principal Investigator","100481338","a-study-of-venoarterial-ecmo-vs-off-pump-bilateral-orthotopic-lung-transplantation-100481338",false,"NCT05547698","A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation","Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation VIP BOLT Trial: A Multicenter Prospective Randomized Trial","Inclusion Criteria:\n\n* Bilateral Lung Transplantation (LTx) recipients.\n* Mean pulmonary artery pressure \\\u003C or = 35 mmHg.\n* Eligible for off-pump or VA ECMO based on the judgement of the attending surgeon.\n\nExclusion Criteria:\n\n* Single lung transplant\n* Multiorgan transplant.\n* Donor after cardiac death (DCD).\n* Re-transplant.\n* Intention to use prophylactic post-operative ECMO.\n* Previous major lung surgery. Video-assisted thoracoscopic surgery (VATS) and wedge resection are not an exclusion criterion.\n* Previous pleurodesis.\n* Preoperative ECMO and\u002For mechanical ventilation.","ALL","18 Years",{"count":111,"type":112},228,"ESTIMATED","INTERVENTIONAL",[115],"NA","The purpose of this research study is to compare the technique of performing bilateral lung transplantation off-pump vs venoarterial ECMO (VA ECMO). The goal of the trial is to determine which technique has lower rates of primary graft dysfunction.",[118],"Lung Transplant",[120],"Bilateral","2026-04-27",{"date":123,"type":124},"2026-05-01","ACTUAL",{"date":126,"type":124},"2022-09-17",{"date":128,"type":112},"2027-09",{"name":5,"class":6},3]