Liver Transplant DisorderNCT04316468
Cardiac Strain Using Speckle Tracking Echocardiography During Orthotopic Liver Transplantation
An observational study of Liver Transplant Disorder and Reperfusion Injury, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to improve the understanding of systolic function of the heart at the time of liver reperfusion in patients undergoing orthotopic liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Disorder, Reperfusion Injury
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2020to 8 Apr 2024
- 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: Sequential liver transplant candidates (adults) will be approached for consent to participate in the study at the time of liver transplantation by a member of the liver anesthesia team.
Who may be able to join
- Age greater than 18 years
- Undergoing primary orthotopic liver transplantation
Who cannot join
- Redo orthotopic transplantation
- Acute or fulminant liver failure
- Patient with pre-existing atrial fibrillation or hypertrophic cardiomyopathy
- Patients with an abnormal preoperative stress test (EF <55%, areas of prior infarct, ongoing ischemia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Cardiac Strain Using Speckle Tracking Echocardiography During Orthotopic Liver Transplantation
Researchers are trying to improve the understanding of systolic function of the heart at the time of liver reperfusion in patients undergoing orthotopic liver transplantation.
- Conditions
- Liver Transplant Disorder, Reperfusion Injury
- Medical subject headings
- Reperfusion Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of change in cardiac strain
Evaluate the degree of change to cardiac strain using speckle tracking echocardiography
Measured: Up to 1 hour after graft reperfusion
Secondary outcomes (1)
Pattern of right and left ventricular strain
Describe the pattern of right and left ventricular strain throughout the course of orthotopic liver transplantion.
Measured: Up to 5 hours from the time of surgery start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start10 Mar 2020
- Primary completion8 Apr 2024
- Study completion8 Apr 2024
Why it stopped: Unable to find software to open saved images for analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Aniskevich, III, Mayo Clinic
- Investigators
- Stephen Aniskevich, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316468
- Sponsor's protocol ID
- 20-001209
- Status last verified
- Apr 2024
- First submitted
- 19 Mar 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiac Strain Using Speckle Tracking Echocardiography During Orthotopic Liver Transplantation
- ClinicalTrials.gov ID
- NCT04316468
- Acronym / sponsor ID
- 20-001209
- Conditions
- Liver Transplant Disorder, Reperfusion Injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to find software to open saved images for analysis
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 20 Mar 2020 (actual)
- 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.
Researchers are trying to improve the understanding of systolic function of the heart at the time of liver reperfusion in patients undergoing orthotopic liver transplantation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sequential liver transplant candidates (adults) will be approached for consent to participate in the study at the time of liver transplantation by a member of the liver anesthesia team.
Key inclusion criteria (2 listed)
- Age greater than 18 years
- Undergoing primary orthotopic liver transplantation
Key exclusion criteria (4 listed)
- Redo orthotopic transplantation
- Acute or fulminant liver failure
- Patient with pre-existing atrial fibrillation or hypertrophic cardiomyopathy
- Patients with an abnormal preoperative stress test (EF <55%, areas of prior infarct, ongoing ischemia)
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
Degree of change in cardiac strain
Time frame: Up to 1 hour after graft reperfusion
Evaluate the degree of change to cardiac strain using speckle tracking echocardiography
1 secondary outcome
Pattern of right and left ventricular strain
Time frame: Up to 5 hours from the time of surgery start
Results and safety
The study was stopped early (reason given: Unable to find software to open saved images for analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Stephen Aniskevich, MD principal investigator
Mayo Clinic
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 Disorder and Reperfusion Injury, run by Mayo Clinic 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 10 Apr 2024. 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 was stopped early (reason given: Unable to find software to open saved images for analysis). Results are not available in the source record.
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.
What does the primary outcome measure?
Degree of change in cardiac strain (time frame: Up to 1 hour after graft reperfusion). It is what the study was designed to measure, not a finding.
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 10 Apr 2024.