Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-02 @ 4:00 PM
Study NCT ID:
NCT02449694
Status:
COMPLETED
Last Update Posted:
2018-04-06
First Post:
2015-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-04', 'studyFirstSubmitDate': '2015-05-11', 'studyFirstSubmitQcDate': '2015-05-15', 'lastUpdatePostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of donor livers preserved by OCS in a near physiologic state.', 'timeFrame': 'Within 1 day of organ retrieval'}, {'measure': 'Number of events directly related to the use of the OCS Liver that led to the donor liver being deemed not clinically acceptable and, as a result, not transplanted', 'timeFrame': 'Within 1 day of organ retrieval'}], 'secondaryOutcomes': [{'measure': 'Number of donor livers maintained in a metabolically active and functioning state during preservation.', 'timeFrame': 'Within 1 day of organ retrieval'}, {'measure': 'Number of donor livers monitored for perfusate temperatures, SvO2, hematocrit, Hepatic Artery flow rates, Portal Vein flow rate, Hepatic Artery pressure, Portal vein pressure, and bile production during preservation.', 'timeFrame': 'Within 1 day of organ retrieval'}, {'measure': 'Frequency of liver graft-related serious adverse events', 'timeFrame': '30 days after transplantation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Liver Preservation']}, 'descriptionModule': {'briefSummary': 'A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Registered male or female primary Liver transplant candidate\n* Age ≥18 years old\n* Signed: written informed consent\n\nExclusion Criteria:\n\n* Acute, fulminant liver failure;\n* Prior solid organ or bone marrow transplant;\n* Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of \\>3 mg/dl (\\>265 mmol/L) for \\>2 weeks and/or requiring hemodialysis;\n* Multi-organ transplant;\n* Ventilator dependent;\n* Dependent on \\> 1 IV inotrope to maintain hemodynamics;\n* Malignancy excluding HCC;\n* Infection.'}, 'identificationModule': {'nctId': 'NCT02449694', 'acronym': 'REVIVE', 'briefTitle': 'Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'TransMedics'}, 'officialTitle': 'Single-arm Prospective Trial to Evaluate The Safety and Performance of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation', 'orgStudyIdInfo': {'id': 'OCS-LVR-022015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OCS Liver', 'description': 'OCS Liver will be used to preserve the donor liver', 'interventionNames': ['Device: OCS Liver']}], 'interventions': [{'name': 'OCS Liver', 'type': 'DEVICE', 'description': 'OCS Liver will be used to preserve the donor liver', 'armGroupLabels': ['OCS Liver']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS9 7 TF', 'city': 'Leeds', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': "St. James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TransMedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}