Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 8:34 AM
Study NCT ID:
NCT01630434
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2012-06-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ldamme@transmedics.com', 'phone': '978.552.0900', 'title': 'VP, Clinical Affairs', 'organization': 'TransMedics, Inc.'}, 'certainAgreement': {'otherDetails': "Site shall have right to publish results. To balance this right with TransMedics' (TM) proprietary interests, site will submit manuscripts intended for publication for TM's review at least 60d prior to submission date. TM will complete its review within 60d of receipt. TM may request that site delete from its manuscripts any reference to TM confidential information and site shall promptly comply with such request. After 60d period, site will have right to publish manuscript, as amended by TM.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant.', 'description': 'The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).', 'eventGroups': [{'id': 'EG000', 'title': 'OCS Lung (Treatment Group)', 'description': 'The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.\n\nOCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 151, 'otherNumAffected': 125, 'seriousNumAtRisk': 150, 'deathsNumAffected': 24, 'seriousNumAffected': 83}, {'id': 'EG001', 'title': 'Cold Flush and Storage (Control Group)', 'description': 'Donor lungs will be preserved using cold flush and storage (control group)\n\nCold flush and storage: Donor lungs will preserved using standard cold flush and storage', 'otherNumAtRisk': 169, 'deathsNumAtRisk': 169, 'otherNumAffected': 141, 'seriousNumAtRisk': 169, 'deathsNumAffected': 27, 'seriousNumAffected': 107}], 'otherEvents': [{'term': 'Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 79, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 95, 'numAffected': 69}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 52, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 72, 'numAffected': 54}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 39, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 48, 'numAffected': 46}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 25, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Immune system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 36, 'numAffected': 32}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood and lymphatic system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatobiliary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical and medical procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congenital, familial and genetic disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocrine disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear and labyrinth disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 54, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 66, 'numAffected': 51}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 36, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 65, 'numAffected': 50}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Immune system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood and lymphatic system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatobiliary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical and medical procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congenital, familial and genetic disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'A Composite of Patient Survival at Day 30 Post Transplantation, and Absence of International Society for Heart & Lung Transplantation (ISHLT) Primary Graft Dysfunction (PGD3) Grade 3 Within the First 72 Hours Post-transplantation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '169', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'OCS Lung (Treatment Group) - Per Protocol', 'description': 'The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.\n\nOCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).'}, {'id': 'OG001', 'title': 'Cold Flush and Storage (Control Group) - Per Protocol', 'description': 'Donor lungs will be preserved using cold flush and storage (control group)\n\nCold flush and storage: Donor lungs will preserved using standard cold flush and storage'}, {'id': 'OG002', 'title': 'OCS Lung (Treatment Group) - ITT', 'description': 'The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.\n\nOCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).'}, {'id': 'OG003', 'title': 'Cold Flush and Storage (Control Group) - ITT', 'description': 'Donor lungs will be preserved using cold flush and storage (control group)\n\nCold flush and storage: Donor lungs will preserved using standard cold flush and storage'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference of proportion', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-0.091', 'ciUpperLimit': '-0.01', 'statisticalMethod': 'Wald Method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin, which is here taken to be 0.04.'}, {'pValue': '0.06', 'groupIds': ['OG002', 'OG003'], 'paramType': 'difference of proportion', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-0.038', 'ciUpperLimit': '0.045', 'statisticalMethod': 'Wald Method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin, which is here taken to be 0.04.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30 after transplantation', 'description': 'This composite is a single outcome measure. Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participants With International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 Hours Post-transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '169', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'OCS Lung (Treatment Group) - Per Protocol', 'description': 'The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.\n\nOCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).'}, {'id': 'OG001', 'title': 'Cold Flush and Storage (Control Group) - Per Protocol', 'description': 'Donor lungs will be preserved using cold flush and storage (control group)\n\nCold flush and storage: Donor lungs will preserved using standard cold flush and storage'}, {'id': 'OG002', 'title': 'OCS Lung (Treatment Group) - ITT', 'description': 'The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.\n\nOCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).'}, {'id': 'OG003', 'title': 'Cold Flush and Storage (Control Group) - ITT', 'description': 'Donor lungs will be preserved using cold flush and storage (control group)\n\nCold flush and storage: Donor lungs will preserved using standard cold flush and storage'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of proportions', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-0.015', 'ciUpperLimit': '0.016', 'statisticalMethod': 'Wald Method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin is 5%.'}, {'pValue': '0.027', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of proportions', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.006', 'ciUpperLimit': '0.044', 'statisticalMethod': 'Wald Method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin is 5%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours after transplantation', 'description': 'Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participants With ISHLT PGD Grade 2 or 3 at 72 Hours Post-transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '169', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'OCS Lung (Treatment Group) - Per Protocol', 'description': 'The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.\n\nOCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).'}, {'id': 'OG001', 'title': 'Cold Flush and Storage (Control Group) - Per Protocol', 'description': 'Donor lungs will be preserved using cold flush and storage (control group)\n\nCold flush and storage: Donor lungs will preserved using standard cold flush and storage'}, {'id': 'OG002', 'title': 'OCS Lung (Treatment Group) - ITT', 'description': 'The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.\n\nOCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).'}, {'id': 'OG003', 'title': 'Cold Flush and Storage (Control Group) - ITT', 'description': 'Donor lungs will be preserved using cold flush and storage (control group)\n\nCold flush and storage: Donor lungs will preserved using standard cold flush and storage'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.118', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of proportions', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.035', 'ciUpperLimit': '0.091', 'statisticalMethod': 'Wald Method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin is 7.5%.'}, {'pValue': '0.389', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of proportions', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.065', 'ciUpperLimit': '0.124', 'statisticalMethod': 'Wald Method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin is 7.5%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours after transplantation', 'description': 'Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Survival at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '169', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'OCS Lung (Treatment Group) - Per Protocol', 'description': 'The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.\n\nOCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).'}, {'id': 'OG001', 'title': 'Cold Flush and Storage (Control Group) - Per Protocol', 'description': 'Donor lungs will be preserved using cold flush and storage (control group)\n\nCold flush and storage: Donor lungs will preserved using standard cold flush and storage'}, {'id': 'OG002', 'title': 'OCS Lung (Treatment Group) - ITT', 'description': 'The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.\n\nOCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).'}, {'id': 'OG003', 'title': 'Cold Flush and Storage (Control Group) - ITT', 'description': 'Donor lungs will be preserved using cold flush and storage (control group)\n\nCold flush and storage: Donor lungs will preserved using standard cold flush and storage'}], 'classes': [{'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of proportions', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.043', 'ciUpperLimit': '0.071', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin is 4%'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of proportions', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.054', 'ciUpperLimit': '0.087', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin is 4%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Primary Safety Endpoint: Lung Graft-related Serious Adverse Events (LGRSAEs) Through 30-days Post-transplant Per Subject', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OCS Lung (Treatment Group)', 'description': 'The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.\n\nOCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).'}, {'id': 'OG001', 'title': 'Cold Flush and Storage (Control Group)', 'description': 'Donor lungs will be preserved using cold flush and storage (control group)\n\nCold flush and storage: Donor lungs will preserved using standard cold flush and storage'}], 'classes': [{'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.47'}, {'value': '0.28', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.47'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-0.045', 'ciUpperLimit': '0.047', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin is 0.7.'}], 'paramType': 'MEAN', 'timeFrame': '30 days post-transplant', 'description': 'An LGRSAE event is defined as the occurrence of any of the following four categories of adverse events that are also serious; acute rejection, respiratory failure, bronchial anastomotic complication, and major pulmonary-related infection.', 'unitOfMeasure': 'events per participant', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was done on the safety population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Long-term Survival: 24-month Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '169', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'OCS Lung (Treatment Group) - Per Protocol', 'description': 'The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.\n\nOCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).'}, {'id': 'OG001', 'title': 'Cold Flush and Storage (Control Group) - Per Protocol', 'description': 'Donor lungs will be preserved using cold flush and storage (control group)\n\nCold flush and storage: Donor lungs will preserved using standard cold flush and storage'}, {'id': 'OG002', 'title': 'OCS Lung (Treatment Group) - ITT', 'description': 'The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.\n\nOCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).'}, {'id': 'OG003', 'title': 'Cold Flush and Storage (Control Group) - ITT', 'description': 'Donor lungs will be preserved using cold flush and storage (control group)\n\nCold flush and storage: Donor lungs will preserved using standard cold flush and storage'}], 'classes': [{'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OCS Lung (Treatment Group)', 'description': 'The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.\n\nOCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).'}, {'id': 'FG001', 'title': 'Cold Flush and Storage (Control Group)', 'description': 'Donor lungs will be preserved using cold flush and storage (control group)\n\nCold flush and storage: Donor lungs will preserved using standard cold flush and storage'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Intention-to-treat population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '169'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '169'}]}, {'type': 'Per Protocol Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '165'}]}, {'type': 'COMPLETED', 'comment': 'Number of per protocol subjects that completed 24-month follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Donor lungs turned down', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '26'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'OCS Lung (Treatment Group)', 'description': 'The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.\n\nOCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).'}, {'id': 'BG001', 'title': 'Cold Flush and Storage (Control Group)', 'description': 'Donor lungs will be preserved using cold flush and storage (control group)\n\nCold flush and storage: Donor lungs will preserved using standard cold flush and storage'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'spread': '14.4', 'groupId': 'BG000'}, {'value': '40.2', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '41.1', 'spread': '14.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Donor Age (years)', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.4', 'spread': '13.1', 'groupId': 'BG000'}, {'value': '50.0', 'spread': '13.6', 'groupId': 'BG001'}, {'value': '50.2', 'spread': '13.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Recipient Age (years)', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Donor Sex (Male/Female)', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Recipient Sex (Male/Female)', 'unitOfMeasure': 'Participants'}, {'title': 'Donor Smoking History in Past 6 Months', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Final PaO2:FiO2 (mm Hg)', 'classes': [{'categories': [{'measurements': [{'value': '438.5', 'spread': '80.0', 'groupId': 'BG000'}, {'value': '431.7', 'spread': '73.8', 'groupId': 'BG001'}, {'value': '434.9', 'spread': '76.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Recipient Transplant Indication', 'classes': [{'categories': [{'title': 'COPD', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Pulmonary Fibrosis', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Cystic Fibrosis', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Idiopathic Pulmonary Hypertension', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Sarcoidosis', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Recipient Lung Allocation Score', 'classes': [{'categories': [{'measurements': [{'value': '50.8', 'spread': '20.9', 'groupId': 'BG000'}, {'value': '47.9', 'spread': '18.7', 'groupId': 'BG001'}, {'value': '49.3', 'spread': '19.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Recipient lung allocation score (LAS) is the value that determines a recipient's urgency on the waitlist. This score is assigned on a scale of 0 to 100, 0 being the least urgent and 100 being the most urgent recipient.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Recipient BMI', 'classes': [{'categories': [{'measurements': [{'value': '23.2', 'spread': '4.6', 'groupId': 'BG000'}, {'value': '23.0', 'spread': '4.1', 'groupId': 'BG001'}, {'value': '23.1', 'spread': '4.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent-to-treat Population'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'dispFirstSubmitDate': '2015-11-02', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-31', 'studyFirstSubmitDate': '2012-06-25', 'dispFirstSubmitQcDate': '2016-05-19', 'resultsFirstSubmitDate': '2022-04-06', 'studyFirstSubmitQcDate': '2012-06-26', 'dispFirstPostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-10', 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Primary Safety Endpoint: Lung Graft-related Serious Adverse Events (LGRSAEs) Through 30-days Post-transplant Per Subject', 'timeFrame': '30 days post-transplant', 'description': 'An LGRSAE event is defined as the occurrence of any of the following four categories of adverse events that are also serious; acute rejection, respiratory failure, bronchial anastomotic complication, and major pulmonary-related infection.'}, {'measure': 'Long-term Survival: 24-month Survival', 'timeFrame': '24 months'}], 'primaryOutcomes': [{'measure': 'A Composite of Patient Survival at Day 30 Post Transplantation, and Absence of International Society for Heart & Lung Transplantation (ISHLT) Primary Graft Dysfunction (PGD3) Grade 3 Within the First 72 Hours Post-transplantation.', 'timeFrame': 'Day 30 after transplantation', 'description': 'This composite is a single outcome measure. Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.'}], 'secondaryOutcomes': [{'measure': 'Participants With International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 Hours Post-transplantation', 'timeFrame': '72 hours after transplantation', 'description': 'Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.'}, {'measure': 'Participants With ISHLT PGD Grade 2 or 3 at 72 Hours Post-transplantation', 'timeFrame': '72 hours after transplantation', 'description': 'Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.'}, {'measure': 'Patient Survival at Day 30', 'timeFrame': 'Day 30'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lung Preservation']}, 'referencesModule': {'references': [{'pmid': '29650408', 'type': 'DERIVED', 'citation': 'Warnecke G, Van Raemdonck D, Smith MA, Massard G, Kukreja J, Rea F, Loor G, De Robertis F, Nagendran J, Dhital KK, Moradiellos Diez FJ, Knosalla C, Bermudez CA, Tsui S, McCurry K, Wang IW, Deuse T, Leseche G, Thomas P, Tudorache I, Kuhn C, Avsar M, Wiegmann B, Sommer W, Neyrinck A, Schiavon M, Calabrese F, Santelmo N, Olland A, Falcoz PE, Simon AR, Varela A, Madsen JC, Hertz M, Haverich A, Ardehali A. Normothermic ex-vivo preservation with the portable Organ Care System Lung device for bilateral lung transplantation (INSPIRE): a randomised, open-label, non-inferiority, phase 3 study. Lancet Respir Med. 2018 May;6(5):357-367. doi: 10.1016/S2213-2600(18)30136-X. Epub 2018 Apr 9.'}, {'pmid': '25284600', 'type': 'DERIVED', 'citation': 'Bozso S, Freed D, Nagendran J. Successful transplantation of extended criteria lungs after prolonged ex vivo lung perfusion performed on a portable device. Transpl Int. 2015 Feb;28(2):248-50. doi: 10.1111/tri.12474. Epub 2014 Oct 27. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'A prospective, international, multi-center, randomized controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush and storage (Control Group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Registered primary double-lung transplant candidate\n* Age \\> or equal to 18\n* Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information\n\nExclusion Criteria:\n\n* Prior solid organ or bone marrow transplant\n* Single lung recipient\n* Multiple organ transplant recipient\n* Chronic use of hemodialysis or diagnosis of chronic renal insufficiency'}, 'identificationModule': {'nctId': 'NCT01630434', 'acronym': 'INSPIRE', 'briefTitle': 'International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'TransMedics'}, 'officialTitle': 'Prospective, International, Multi-Center, Randomized Clinical Investigation of TransMedics Organ Care System (OCS LUNG) for Lung Preservation and Transplantation', 'orgStudyIdInfo': {'id': 'OCS-LUN-03-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OCS Lung (Treatment Group)', 'description': 'The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.', 'interventionNames': ['Device: OCS Lung']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cold flush and storage (Control Group)', 'description': 'Donor lungs will be preserved using cold flush and storage (control group)', 'interventionNames': ['Device: Cold flush and storage']}], 'interventions': [{'name': 'OCS Lung', 'type': 'DEVICE', 'description': 'OCS Lung will be used to preserve the donor lungs (Treatment Group).', 'armGroupLabels': ['OCS Lung (Treatment Group)']}, {'name': 'Cold flush and storage', 'type': 'DEVICE', 'otherNames': ['Commercially available cold preservation solution'], 'description': 'Donor lungs will preserved using standard cold flush and storage', 'armGroupLabels': ['Cold flush and storage (Control Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "St. Joseph's Hospital and Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California at San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'T6G 2C8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': '13915', 'city': 'Marseille', 'country': 'France', 'facility': 'University Hospitals of Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '18 eme', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Hopitaux Universitaries', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'N.H.C Hospital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': 'D-13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'German Heart Institute Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitäres Herzzentrum Hamburg GmbH', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': 'D-300625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Hannover Medical School', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'University of Padua', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '28222', 'city': 'Madrid', 'country': 'Spain', 'facility': 'University Puerta de Hierro Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'CB23 3 RE', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Papworth Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'UB9 6JH', 'city': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Harefield Hospital', 'geoPoint': {'lat': 51.53174, 'lon': -0.26856}}], 'overallOfficials': [{'name': 'Abbas Ardehali, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ronald Reagan Medical Center, UCLA'}, {'name': 'Dirk van Raemodonck, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UZ Leuven, Belgium'}, {'name': 'Gregor Warnecke, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hannover Medical Center, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TransMedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}