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Enrollment in Liver DCD was stopped as a result of the FDA approval for the OCS Liver System and follow-up ended on 12/16/2024 based on adequate patient follow-up.
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Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.
To evaluate the safety and effectiveness of the OCS™ Liver to preserve, optimize the condition and assess livers from DCD donors that currently are seldom used for liver transplants due to limitations of cold static storage with extended warm ischemic time and older donors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCS Preserved Livers | Experimental | This is a single-arm trial of OCS preserved livers used for transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCS Liver System | Device | The OCS Liver System will be used to preserve, optimize and assess livers from DCD donors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liver Graft Survival Through 6 Months Post-transplant | Evaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Elbetanony, MD | TransMedics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Henry Ford Hospital |
| 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 | OCS Preserved Livers | OCS Liver System: OCS Liver System for preserving and assessing donor livers for transplantation from DCD donors. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OCS Preserved Livers | OCS Liver System: OCS Liver System for preserving and assessing donor livers for transplantation from DCD donors. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Liver Graft Survival Through 6 Months Post-transplant | Evaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation | Posted | Count of Participants | Participants | 6 months |
|
|
Liver graft-related serious adverse events (LGRSAEs) were collected up to the 30-day follow-up after transplantation. Ischemic biliary cholangiopathy was collected at 6 months post-transplant. Reporting of all-cause mortality is through 6-months post transplant.
Per the protocol only liver graft-related serious adverse events (LGRSAEs) and serious adverse events (SAEs) will be collected through Day 30 post-transplant. Ischemic biliary cholangiopathy was collected at 6 months post-transplant.
Other (Not Including Serious) Adverse Events were not collected and therefore not reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OCS Preserved Livers | OCS Liver System: OCS Liver System for preserving and assessing donor livers for transplantation from DCD donors. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intra-abdominal Hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Cliinical Affairs | TransMedics, Inc. | 978-552-0900 | ldamme@transmedics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 26, 2019 | Nov 11, 2024 | Prot_SAP_000.pdf |
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| Detroit |
| Michigan |
| 48202 |
| United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| University of Texas San Antonio | San Antonio | Texas | 78249 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 0 |
| 9 |
| 3 |
| 9 |
| 0 |
| 0 |
| Hepatic Artery Dissection | Vascular disorders | Systematic Assessment |
|
| Ischemic Biliary Stricture | Hepatobiliary disorders | Systematic Assessment |
|
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 30d prior to submission date. TM will complete its review within 30d 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.