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| Name | Class |
|---|---|
| North American Science Associates Ltd. | NETWORK |
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A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human liver transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normothermic Machine Perfusion (NMP) | Experimental | Following the routine retrieval procedure of the liver, it will be placed on the OrganOx metra for Normothermic Machine Perfusion (NMP) for transport per the Investigational Plan and the Instructions For Use. |
|
| Standard of Care (Ice) | Other | Following the routine retrieval procedure of the liver, it will be placed in ice-cold perfusion solution within an ice box for transport as dictated by logistics and local policy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normothermic Machine Perfusion (NMP) | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Early Allograft Dysfunction (EAD) | EAD is a binary outcome defined by the presence of one of the following 3 outcomes:
| 7 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Primary Non-Function | Primary Non-Function is defined in this study as irreversible graft dysfunction requiring emergency liver replacement during the first 10 days after liver transplantation. | 10 Days |
| Number of Participants With Graft Survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Knechtle, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Mayo Clinic - Phoenix |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33650998 | Derived | Kubal C, Mihaylov P, Holden J. Oncologic indications of liver transplantation and deceased donor liver allocation in the United States. Curr Opin Organ Transplant. 2021 Apr 1;26(2):168-175. doi: 10.1097/MOT.0000000000000866. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normothermic Machine Perfusion (NMP) | Following the routine retrieval procedure of the liver, it will be placed on the OrganOx metra for Normothermic Machine Perfusion (NMP) for transport per the Investigational Plan and the Instructions For Use. Normothermic Machine Perfusion (NMP) |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 24, 2016 | May 9, 2022 |
Not provided
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| Standard of Care (Ice) |
| Other |
|
| 6 Months |
| Number of Participants With Subject Survival | 6 Months |
| Number of Participants With Post-Reperfusion Syndrome | Post-Reperfusion Syndrome is defined in this study as a decrease in mean arterial pressure (MAP) of more than 30% from the baseline value for more than one minute during the first five minutes after reperfusion. | 1 Day |
| Measure Biochemical Liver Function Via Bilirubin | 6 Months |
| Measure Biochemical Liver Function Via Gamma-Glutamyl Transferase (GGT) | 6 Months |
| Measure Biochemical Liver Function Via Alanine Aminotransferase (ALT) | 6 Months |
| Measure Biochemical Liver Function Via Aspartate Transaminase (AST) | 6 Months |
| Measure Biochemical Liver Function Via Alkaline Phosphatase (ALP) | 6 Months |
| Measure Biochemical Liver Function Via International Normalized Ratio (INR) | The international normalized ratio (INR) is a laboratory measurement of how long it takes blood to form a clot. It is calculated using the following formula: INR = (PT [test] / PT [control])^ISI INR = international normalized ratio PT [test] = tested prothrombin time PT [control] = control prothrombin time ISI = international sensitivity index | 6 Months |
| Measure Biochemical Liver Function Via Lactate | Days 1-7 |
| Number of Participants With Evidence of Ischemia-Reperfusion Injury Via Comparison of Pre-Reperfusion Biopsies to Post-Reperfusion Biopsies | Overall Degree of Ischemia Reperfusion Injury (IRI) was categorized as:
| 1 Day |
| Number of Participants With Biliary Investigations and Biliary Interventions | 6 Months |
| Number of Livers Randomized But Not Transplanted | 1 Day |
| Number of Livers That Did Not Experience a Safety Event | Number of livers that did not experience at least one of the following safety events:
| 10 Days |
| Assessment of the Health Economic Implications Via Length of ICU Stay and Length of Hospital Stay | 6 Months |
| Compare Quality of Life Via the EQ-5D-5L Quality of Life Questionnaire | The EQ-5D-5L Questionnaire is the standard layout for recording an adult person's current self-reported health state. It consists of a standard format for respondents to record their health state according to the EQ-5D-5L descriptive system and the EQ Visual Analog Scale (VAS). EQ-5D-5L index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health. EQ-5D-5L is the name of the instrument and is not an acronym. | 6 Months |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| University of Southern California (USC) | Los Angeles | California | 90033 | United States |
| University of California - Los Angeles (UCLA) | Los Angeles | California | 90095 | United States |
| University of California-San Francisco (UCSF) | San Francisco | California | 94153 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Ochsner | New Orleans | Louisiana | 70121 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Wisconsin Madison | Madison | Wisconsin | 53792 | United States |
| Standard of Care (Ice) |
Following the routine retrieval procedure of the liver, it will be placed in ice-cold perfusion solution within an ice box for transport as dictated by logistics and local policy. Standard of Care (Ice) |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Normothermic Machine Perfusion (NMP) | Following the routine retrieval procedure of the liver, it will be placed on the OrganOx metra for Normothermic Machine Perfusion (NMP) for transport per the Investigational Plan and the Instructions For Use. Normothermic Machine Perfusion (NMP) |
| BG001 | Standard of Care (Ice) | Following the routine retrieval procedure of the liver, it will be placed in ice-cold perfusion solution within an ice box for transport as dictated by logistics and local policy. Standard of Care (Ice) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Early Allograft Dysfunction (EAD) | EAD is a binary outcome defined by the presence of one of the following 3 outcomes:
| There was one subject excluded from the primary endpoint analysis as there was only an attempt to transplant a randomized liver. The subject was deemed unable to proceed with the liver transplant and was followed through 30-days post-transplant for adverse event collection only. | Posted | Number | 95% Confidence Interval | percentage of participants | 7 Days |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Primary Non-Function | Primary Non-Function is defined in this study as irreversible graft dysfunction requiring emergency liver replacement during the first 10 days after liver transplantation. | The overall number of participants analyzed reflects participants in each arm who were eligible to be included in the analysis and had complete data. | Posted | Count of Participants | Participants | 10 Days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Graft Survival | The overall number of participants analyzed reflects participants in each arm who were eligible to be included in the analysis and had complete data. | Posted | Count of Participants | Participants | 6 Months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Subject Survival | The overall number of participants analyzed reflects participants in each arm who were eligible to be included in the analysis and had complete data. | Posted | Count of Participants | Participants | 6 Months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Post-Reperfusion Syndrome | Post-Reperfusion Syndrome is defined in this study as a decrease in mean arterial pressure (MAP) of more than 30% from the baseline value for more than one minute during the first five minutes after reperfusion. | The overall number of participants analyzed reflects participants in each arm who were eligible to be included in the analysis and had complete data. | Posted | Count of Participants | Participants | 1 Day |
|
| ||||||||||||||||||||||||||||||
| Secondary | Measure Biochemical Liver Function Via Bilirubin | The overall number of participants analyzed reflects participants in each arm who were eligible to be included in the analysis and had complete data. | Posted | Median | Inter-Quartile Range | mg/dL | 6 Months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Measure Biochemical Liver Function Via Gamma-Glutamyl Transferase (GGT) | The overall number of participants analyzed reflects participants in each arm who were eligible to be included in the analysis and had complete data. | Posted | Median | Inter-Quartile Range | IU/L | 6 Months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Measure Biochemical Liver Function Via Alanine Aminotransferase (ALT) | The overall number of participants analyzed reflects participants in each arm who were eligible to be included in the analysis and had complete data. | Posted | Median | Inter-Quartile Range | IU/L | 6 Months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Measure Biochemical Liver Function Via Aspartate Transaminase (AST) | The overall number of participants analyzed reflects participants in each arm who were eligible to be included in the analysis and had complete data. | Posted | Median | Inter-Quartile Range | IU/L | 6 Months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Measure Biochemical Liver Function Via Alkaline Phosphatase (ALP) | The overall number of participants analyzed reflects participants in each arm who were eligible to be included in the analysis and had complete data. | Posted | Median | Inter-Quartile Range | IU/L | 6 Months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Measure Biochemical Liver Function Via International Normalized Ratio (INR) | The international normalized ratio (INR) is a laboratory measurement of how long it takes blood to form a clot. It is calculated using the following formula: INR = (PT [test] / PT [control])^ISI INR = international normalized ratio PT [test] = tested prothrombin time PT [control] = control prothrombin time ISI = international sensitivity index | The overall number of participants analyzed reflects participants in each arm who were eligible to be included in the analysis and had complete data. | Posted | Median | Inter-Quartile Range | No Units | 6 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Measure Biochemical Liver Function Via Lactate | The overall number of participants analyzed reflects participants in each arm who were eligible to be included in the analysis and had complete data. | Posted | Median | Inter-Quartile Range | mmol/L | Days 1-7 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Evidence of Ischemia-Reperfusion Injury Via Comparison of Pre-Reperfusion Biopsies to Post-Reperfusion Biopsies | Overall Degree of Ischemia Reperfusion Injury (IRI) was categorized as:
| The overall number of participants analyzed reflects participants in each arm who were eligible to be included in the analysis and had complete data. | Posted | Count of Participants | Participants | 1 Day |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Biliary Investigations and Biliary Interventions | The overall number of participants analyzed reflects participants in each arm who were eligible to be included in the analysis and had complete data. | Posted | Count of Participants | Participants | 6 Months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Livers Randomized But Not Transplanted | The analysis population for this outcome reflects all livers randomized in the study; therefore, the number analyzed is greater than the participants enrolled. | Posted | Count of Units | Livers | 1 Day | Livers | Livers |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Livers That Did Not Experience a Safety Event | Number of livers that did not experience at least one of the following safety events:
| The analysis population for this outcome reflects all livers retrieved in the study; therefore, the number analyzed is greater than the participants enrolled, but less than the total livers randomized. There was one subject where there was only an attempt to transplant a randomized liver as the subject was deemed unable to proceed with the liver transplant. | Posted | Count of Units | Livers | 10 Days | Livers | Livers |
| |||||||||||||||||||||||||||||
| Secondary | Assessment of the Health Economic Implications Via Length of ICU Stay and Length of Hospital Stay | The overall number of participants analyzed reflects participants in each arm who were eligible to be included in the analysis and had complete data. | Posted | Mean | Standard Deviation | Days | 6 Months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Compare Quality of Life Via the EQ-5D-5L Quality of Life Questionnaire | The EQ-5D-5L Questionnaire is the standard layout for recording an adult person's current self-reported health state. It consists of a standard format for respondents to record their health state according to the EQ-5D-5L descriptive system and the EQ Visual Analog Scale (VAS). EQ-5D-5L index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health. EQ-5D-5L is the name of the instrument and is not an acronym. | The overall number of participants analyzed reflects participants in each arm who were eligible to be included in the analysis and had complete data. | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
|
Adverse event data were collected from the point of enrollment through study exit (12 months for subjects completing the study).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normothermic Machine Perfusion (NMP) | Following the routine retrieval procedure of the liver, it will be placed on the OrganOx metra for Normothermic Machine Perfusion (NMP) for transport per the Investigational Plan and the Instructions For Use. Normothermic Machine Perfusion (NMP) | 10 | 136 | 95 | 136 | 125 | 136 |
| EG001 | Standard of Care (Ice) | Following the routine retrieval procedure of the liver, it will be placed in ice-cold perfusion solution within an ice box for transport as dictated by logistics and local policy. Standard of Care (Ice) | 4 | 131 | 93 | 131 | 123 | 131 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Infection | Infections and infestations | Systematic Assessment |
| ||
| Blood Infection | Infections and infestations | Systematic Assessment |
| ||
| Biliary Infection | Infections and infestations | Systematic Assessment |
| ||
| Wound Infection | Infections and infestations | Systematic Assessment |
| ||
| Abdominal Infection | Infections and infestations | Systematic Assessment |
| ||
| Gastrointestinal Infection | Infections and infestations | Systematic Assessment |
| ||
| Skin Infection | Infections and infestations | Systematic Assessment |
| ||
| Infection Other | Infections and infestations | Systematic Assessment |
| ||
| Bile Leak | Hepatobiliary disorders | Systematic Assessment |
| ||
| Biliary Stricture (Anastomotic | Hepatobiliary disorders | Systematic Assessment |
| ||
| Ischemic Cholangiopathy | Hepatobiliary disorders | Systematic Assessment |
| ||
| Biliary Other | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatic Artery Thrombosis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatic Artery Stenosis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatic Artery Other | Hepatobiliary disorders | Systematic Assessment |
| ||
| Portal Vein Thrombosis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Graft Dysfunction | Hepatobiliary disorders | Systematic Assessment |
| ||
| Rejection | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cholangitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatic Other | Hepatobiliary disorders | Systematic Assessment |
| ||
| Allery - Drug | Immune system disorders | Systematic Assessment |
| ||
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Coronary Artery Disease | Cardiac disorders | Systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Systematic Assessment |
| ||
| Hypotension | Cardiac disorders | Systematic Assessment |
| ||
| Hypovolemia | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmias | Cardiac disorders | Systematic Assessment |
| ||
| Cardiovascular Other | Cardiac disorders | Systematic Assessment |
| ||
| Hematoma/Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dermatologic Other | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| GI Bleed | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal Other | Gastrointestinal disorders | Systematic Assessment |
| ||
| Renal Dysfunction/Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Oliguria | Renal and urinary disorders | Systematic Assessment |
| ||
| Genitourinary Other | Renal and urinary disorders | Systematic Assessment |
| ||
| Gout | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal Other | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Cold/Flu | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bleeding - No Transfusion Required | General disorders | Systematic Assessment |
| ||
| Bleeding - Transfusion Required | General disorders | Systematic Assessment |
| ||
| Bleeding from Hepatic Artery | General disorders | Systematic Assessment |
| ||
| Bleeding from IVC | General disorders | Systematic Assessment |
| ||
| Bleeding Requiring Reoperation | General disorders | Systematic Assessment |
| ||
| Bleeding Other | General disorders | Systematic Assessment |
| ||
| Abdominal Collection | General disorders | Systematic Assessment |
| ||
| Pleural Effusion | General disorders | Systematic Assessment |
| ||
| Ascites | General disorders | Systematic Assessment |
| ||
| Extremities Edema | General disorders | Systematic Assessment |
| ||
| Fluid Collection Other | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Surgery - Planned/Elective | General disorders | Systematic Assessment |
| ||
| Surgery - Emergency | General disorders | Systematic Assessment |
| ||
| Other Systemic Disease/Event | General disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Malignancy | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hematology Other | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
| ||
| Hyperkalemia | General disorders | Systematic Assessment |
| ||
| Hypernatremia | General disorders | Systematic Assessment |
| ||
| Hyponatremia | General disorders | Systematic Assessment |
| ||
| Altered Mental Status | Psychiatric disorders | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Psychiatric Disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Stroke/TIA | Nervous system disorders | Systematic Assessment |
| ||
| Neurology/Psychiatry Other | Psychiatric disorders | Systematic Assessment |
| ||
| EAD - Serum Bilirubin | Hepatobiliary disorders | Systematic Assessment |
| ||
| EAD - ALT or AST | Hepatobiliary disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hematology Other | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal Other | Gastrointestinal disorders | Systematic Assessment |
| ||
| Tremors | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Altered Mental Status | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Nervous system disorders | Systematic Assessment |
| ||
| Renal Dysfunction/Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Genitourinary Other | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
| ||
| UTI | Renal and urinary disorders | Systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Systematic Assessment |
| ||
| Hypotension | Cardiac disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Hypovolemia | Cardiac disorders | Systematic Assessment |
| ||
| Hypomagnesemia | General disorders | Systematic Assessment |
| ||
| Hyperkalemia | General disorders | Systematic Assessment |
| ||
| Hypokalemia | General disorders | Systematic Assessment |
| ||
| Extremities Edema | General disorders | Systematic Assessment |
| ||
| Pleural Effusion | General disorders | Systematic Assessment |
| ||
| Graft Dysfunction | Hepatobiliary disorders | Systematic Assessment |
| ||
| Rejection | Hepatobiliary disorders | Systematic Assessment |
| ||
| Blood Infection | Infections and infestations | Systematic Assessment |
| ||
| Infection Other | Infections and infestations | Systematic Assessment |
| ||
| Other Systemic Disease/Event | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Musculoskeletal Other | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Respiratory Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dermatologic Other | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| EAD - ALT or AST | Hepatobiliary disorders | Systematic Assessment |
| ||
| Bleeding - Transfusion Required | General disorders | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Bovy, VP of Regulatory Affairs, North America | OrganOx Ltd | 608-556-4429 | robert.bovy@organox.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 9, 2020 | May 9, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D007053 | Ice |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D014887 | Weather |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Livers |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Livers |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Moderate/Severe |
|