Liver TransplantNCT00698399
Serum Markers of Ischemia Reperfusion Injury in Liver Transplant Patients
An observational study of Liver Transplant, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This is an observational study examining serum markers in patients who are undergoing either a cadaveric liver transplant or a living related liver transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to 2 Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from those on the list awaiting liver transplantation at Vanderbilt University Medical Center (VUMC). They will be recruited by the investigators prior to the time of their transplantation surgery
Who may be able to join
- American Society of Anesthesiologists (ASA) Class I-V.
- Patient is undergoing elective Liver Transplant Surgery.
- Patient is an adult, 18 years old or older.
Who cannot join
- Patients < 18 Years of Age
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: Serum Markers of Ischemia Reperfusion Injury in Liver Transplant Patients, Phase II
This is an observational study examining serum markers in patients who are undergoing either a cadaveric liver transplant or a living related liver transplant.
Read the detailed description
The Departments of Anesthesiology are conducting an observational trial of markers in the serum of patients who are undergoing liver transplantation surgery. This study will utilize the biological markers, trimethylamine-N-oxide (TMAO), NGAL, and cystatin-C, sensitive markers of renal medullary injury in the blood and allantoin, a marker of oxidative stress as indicators of renal injury in a kidney during liver transplants. It is hypothesized that: (1) these markers are less pronounced in living donor liver transplant recipient patients than in cadaveric liver transplant recipients, and (2) these markers are less pronounced in cadaveric liver transplant recipients in which a "piggy-back" technique was used versus recipients in which a total venous occlusion technique was used. This study will be done in a multi-center format, along with researchers at UCSF
- Conditions
- Liver Transplant
- Keywords
- liver, transplant, TMAO, NGAL, cystatin-C, Ischemia Reperfusion Injury, Liver Transplant, LTx, allantion
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Live Donor | |
| 2 | Cadaveric Donor |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startMar 2008
- Primary completion2 Feb 2010
- Study completion2 Feb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Jeffrey M Waldman, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698399
- Sponsor's protocol ID
- 80237
- Status last verified
- Feb 2018
- First submitted
- 12 Jun 2008
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Markers of Ischemia Reperfusion Injury in Liver Transplant Patients, Phase II
- ClinicalTrials.gov ID
- NCT00698399
- Acronym / sponsor ID
- 80237
- Conditions
- Liver Transplant
- Keywords
- liver, transplant, TMAO, NGAL, cystatin-C, Ischemia Reperfusion Injury, Liver Transplant, LTx
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- Mar 2008
- Primary completion
- 2 Feb 2010 (actual)
- Study completion
- 2 Feb 2010 (actual)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study examining serum markers in patients who are undergoing either a cadaveric liver transplant or a living related liver transplant.
Detailed description
The Departments of Anesthesiology are conducting an observational trial of markers in the serum of patients who are undergoing liver transplantation surgery. This study will utilize the biological markers, trimethylamine-N-oxide (TMAO), NGAL, and cystatin-C, sensitive markers of renal medullary injury in the blood and allantoin, a marker of oxidative stress as indicators of renal injury in a kidney during liver transplants. It is hypothesized that: (1) these markers are less pronounced in living donor liver transplant recipient patients than in cadaveric liver transplant recipients, and (2) these markers are less pronounced in cadaveric liver transplant recipients in which a "piggy-back" technique was used versus recipients in which a total venous occlusion technique was used. This study will be done in a multi-center format, along with researchers at UCSF
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Live Donor |
| 2 | – | –Cadaveric Donor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from those on the list awaiting liver transplantation at Vanderbilt University Medical Center (VUMC). They will be recruited by the investigators prior to the time of their transplantation surgery
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) Class I-V.
- Patient is undergoing elective Liver Transplant Surgery.
- Patient is an adult, 18 years old or older.
Key exclusion criteria (2 listed)
- Patients < 18 Years of Age
- Patients who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Vanderbilt University Medical Center Department of AnesthesiologyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey M Waldman, M.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.