Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-02-22 @ 10:43 AM
Study NCT ID:
NCT02478151
Status:
UNKNOWN
Last Update Posted:
2022-04-12
First Post:
2014-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Ex-vivo Normothermic Machine Perfusion With the Organox Metra™ Device to Store Human Livers for Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058625', 'term': 'End Stage Liver Disease'}], 'ancestors': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-08', 'studyFirstSubmitDate': '2014-12-01', 'studyFirstSubmitQcDate': '2015-06-17', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of primary graft non-function', 'timeFrame': '3 months'}, {'measure': 'Rates of re-transplantation', 'timeFrame': '3 months'}, {'measure': 'Rates of recipient death', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Rate of device failures resulting in organ discard', 'timeFrame': '3 months'}, {'measure': 'Recruitment rates to the study', 'timeFrame': '3 months', 'description': 'Measured by the ratio of actual / eligible candidate donors recruited to the study'}, {'measure': 'Ischemia- reperfusion injury associated with organ storage', 'timeFrame': '7 days', 'description': 'Assessed by a post-perfusion biopsy'}, {'measure': 'Ischemia- reperfusion injury associated with organ storage', 'timeFrame': '7 days', 'description': 'Assessed by measuring the peak serum aspartate transaminase level (AST) within 7 days post-transplant'}, {'measure': 'The function of liver grafts stored with the Metra™ device', 'timeFrame': '3 months', 'description': 'Measured by bilirubin, alkaline phosphatase, AST and INR levels at days 1-7 post-transplant. The measure is a composite.'}, {'measure': 'The function of liver grafts stored with the Metra™ device', 'timeFrame': '3 months', 'description': 'Measured by bilirubin, alkaline phosphatase, AST and INR levels at day 30 post-transplant. The measure is a composite.'}, {'measure': 'The function of liver grafts stored with the Metra™ device', 'timeFrame': '3 months', 'description': 'Measured by bilirubin, alkaline phosphatase, AST and INR levels at month 3 post-transplant. The measure is a composite.'}, {'measure': 'The function of liver grafts stored with the Metra™ device', 'timeFrame': '3 months', 'description': 'Measured by Lactate at days 1-3 post-transplant. The measure is a composite.'}, {'measure': 'The ability of perfusion parameters to predict clinical outcomes following transplantation', 'timeFrame': '3 months', 'description': 'Perfusion flows and pressures will be studied to determine their correlation with graft injury and function. The measure is a composite.'}, {'measure': 'The ability of perfusion parameters to predict clinical outcomes following transplantation', 'timeFrame': '3 months', 'description': 'Perfusate blood gas parameters will be studied to determine their correlation with graft injury and function. The measure is a composite.'}, {'measure': 'The ability of perfusion parameters to predict clinical outcomes following transplantation', 'timeFrame': '3 months', 'description': 'Bile production will be studied to determine their correlation with graft injury and function'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Deceased donor liver transplant', 'Normothermic machine perfusion'], 'conditions': ['End-stage Liver Disease']}, 'descriptionModule': {'briefSummary': 'This trial will examine the safety and feasibility of using the OrganOx Metra device to transport and store donor livers under normothermic conditions prior to transplantation. Participants will be followed for 3 months following transplantation and their outcomes recorded.', 'detailedDescription': 'Liver transplantation is a life-saving procedure but its success has been limited by a shortage of suitable donor organs. Much emphasis is now placed on optimising the condition of those organs that are available, to enable more higher risk organs to be transplanted safely. An effective means of pre-transplant viability assessment would not only allow greater use of higher risk donors but also minimise the risk of primary non-function by identifying and excluding non-viable organs before subjecting a patient to the risk of surgery. Organ storage under normothermic perfusion conditions enables organ function to be evaluated prior to transplantation and further has been shown to prevent organ injury which is sustained during standard cold storage. This trial will examine the safety and feasibility of using the OrganOx Metra device to transport and store donor livers under normothermic conditions prior to transplantation. This study will evaluate liver function post-transplantation using standard clinical parameters. Participants will be followed for 3 months following transplantation and their outcomes recorded. Participants will undergo no other study procedures. Feasibility will be measured using the ratio of actual / eligible candidate donors recruited to the study and will also encompass logistical issues with respect to transportation, and ease of use. Safety will be assessed by rates of device failures resulting in organ discard, primary graft non-function, re-transplantation, and recipient death.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18 years or more)\n* Active on the waiting list for liver transplantation\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Acute/fulminant liver failure\n* Transplantation of more than one organ (e.g. liver and kidney)\n* Refusal of informed consent\n* Unable to give informed consent\n* Re-transplantation Diagnosis of Hepatopulmonary Syndrome'}, 'identificationModule': {'nctId': 'NCT02478151', 'briefTitle': 'Using Ex-vivo Normothermic Machine Perfusion With the Organox Metra™ Device to Store Human Livers for Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'A Single Centre Study of the Feasibility and Safety of Using Ex-vivo Normothermic Machine Perfusion With the Organox Metra™ Device to Store Human Livers for Transplantation', 'orgStudyIdInfo': {'id': '14-8132-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OrganOx Metra', 'description': 'OrganOx Metra Device', 'interventionNames': ['Device: OrganOx Metra']}], 'interventions': [{'name': 'OrganOx Metra', 'type': 'DEVICE', 'description': 'Normothermic machine perfusion (NMP) Metra device', 'armGroupLabels': ['OrganOx Metra']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'David R Grant, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}