Postoperative Graft FunctionNCT03814031
Hepatic Vein Flow During Orthotopic Liver Transplantation as Predictive Factor for Postoperative Graft Function
An observational study of Postoperative Graft Function, run by Henry Ford Health System at 1 site in United States.
Trial summary
Hepatic vein flow (HVF) assessment using transesophageal echocardiography (TEE) has a potential to predict postoperative graft function in orthotopic liver transplant (OLT). Investigators will measure HVF using TEE and assess the correlation with postoperative graft function indices such as early allograft… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Graft Function
- What is being tested?
- NO internvention
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: OLT with piggy back technique
Who may be able to join
- Orthotopic liver transplants which uses TEE intraoperatively Must be Piggy back technique
- -
Who cannot join
- TEE absolute contraindication patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hepatic Vein Flow Assessment With Transesophageal Echocardiography for Postoperative Graft Function Prediction in Orthotopic Liver Transplantation
Hepatic vein flow (HVF) assessment using transesophageal echocardiography (TEE) has a potential to predict postoperative graft function in orthotopic liver transplant (OLT). Investigators will measure HVF using TEE and assess the correlation with postoperative graft function indices such as early allograft dysfunction(EAD), prolonged INR, platelet, and total bilirubin.
Read the detailed description
During OLT, intraoperative TEE assessment of HVF (systolic and diastolic) were measured, and adjusted with donor graft weight. This index, HVF index, was assessed for correlation with EAD. HVF was calculated with hepatic vein area (cm2) x hepatic vein velocity (ml/s) in systole and diastole during the neohepatic phase. Investigators did ROC analysis to assess the predictive power for EAD, prolonged INR, platelet, and total bilirubin.
- Conditions
- Postoperative Graft Function
- Being tested
- NO internvention
- Keywords
- TEE, orthotopic liver transplant, EAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO internventionOther
NO internvention
| Study group | Role | What they receive |
|---|---|---|
| EAD after orthotopic liver transplantation | Early allograft dysfunction (EAD), which was defined by the presence of one or more of the following: total bilirubin (t-bil) ≥ 10 mg/dL (171 μmol/L) or, INR ≥ 1.6 on day 7, and ALT/AST > 2,000 IU/L within the first 7 days. Receives: Other: NO internvention | |
| No EAD after orthotopic liver transplantation | No EAD Receives: Other: NO internvention |
What is being measured
The primary outcome is the main question the study is designed to answer.
EAD
Primary outcome was early allograft dysfunction (EAD), which was defined by the presence of one or more of the following: total bilirubin (t-bil) ≥ 10 mg/dL (171 μmol/L) or, INR ≥ 1.6 on postoperative day 7. and ALT/AST > 2,000 IU/L
Systolic and diastolic hepatic vein flow index was assessed intraoperatively in neohepatic phase in both of EAD and non EAD group, and reported.
Measured: EAD met at any point within the first 7 days status post OLT
Secondary outcomes (4)
Acute Rejection
Acute rejection noted with biopsy at any point within 6 to 8 weeks post-transplant
Measured: Acute rejection noted at any point within 6-8 weeks post transplant
Prolonged (>Seven Days) Time to Normalize Total Bilirubin (TIME T-bil)
Normal total bilirubin < 1.2 mg/dL
Measured: postoperative day 7 assessment
Prolonged (>Seven Days) Time to Normalize INR (TIME Inr)
Normal INR < 1.16
Measured: postoperative day 7 assessment
Prolonged (>Seven Days) Time to Normalize Platelet Count (TIME Plt).
Normal platelet count > 140 B/L
Measured: postoperative day 7 assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start20 Feb 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative Graft FunctionStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshihisa Morita, Henry Ford Health System
- Investigators
- Yoshihisa Morita, MD, Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814031
- Sponsor's protocol ID
- 12156
- Status last verified
- May 2024
- First submitted
- 16 Jan 2019
- Last updated
- 23 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Vein Flow Assessment With Transesophageal Echocardiography for Postoperative Graft Function Prediction in Orthotopic Liver Transplantation
- ClinicalTrials.gov ID
- NCT03814031
- Acronym / sponsor ID
- 12156
- Conditions
- Postoperative Graft Function
- Keywords
- TEE, orthotopic liver transplant, EAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatic vein flow (HVF) assessment using transesophageal echocardiography (TEE) has a potential to predict postoperative graft function in orthotopic liver transplant (OLT). Investigators will measure HVF using TEE and assess the correlation with postoperative graft function indices such as early allograft dysfunction(EAD), prolonged INR, platelet, and total bilirubin.
Detailed description
During OLT, intraoperative TEE assessment of HVF (systolic and diastolic) were measured, and adjusted with donor graft weight. This index, HVF index, was assessed for correlation with EAD. HVF was calculated with hepatic vein area (cm2) x hepatic vein velocity (ml/s) in systole and diastole during the neohepatic phase. Investigators did ROC analysis to assess the predictive power for EAD, prolonged INR, platelet, and total bilirubin.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EAD after orthotopic liver transplantation | – | Other: NO internventionEarly allograft dysfunction (EAD), which was defined by the presence of one or more of the following: total bilirubin (t-bil) ≥ 10 mg/dL (171 μmol/L) or, INR ≥ 1.6 on day 7, and ALT/AST > 2,000 IU/L within the first 7 days. |
| No EAD after orthotopic liver transplantation | – | Other: NO internventionNo EAD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- OLT with piggy back technique
Key inclusion criteria (2 listed)
- Orthotopic liver transplants which uses TEE intraoperatively Must be Piggy back technique
- -
Key exclusion criteria (1 listed)
- TEE absolute contraindication patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NO internventionNO internvention | Other | EAD after orthotopic liver transplantation, No EAD after orthotopic liver transplantation |
Primary outcome
EAD
Time frame: EAD met at any point within the first 7 days status post OLT
Primary outcome was early allograft dysfunction (EAD), which was defined by the presence of one or more of the following: total bilirubin (t-bil) ≥ 10 mg/dL (171 μmol/L) or, INR ≥ 1.6 on postoperative day 7. and ALT/AST > 2,000 IU/L Systolic and diastolic hepatic vein flow index was assessed intraoperatively in neohepatic phase in both of EAD and non EAD group, and reported.
4 secondary outcomes
Acute Rejection
Time frame: Acute rejection noted at any point within 6-8 weeks post transplant
Prolonged (>Seven Days) Time to Normalize Total Bilirubin (TIME T-bil)
Time frame: postoperative day 7 assessment
Prolonged (>Seven Days) Time to Normalize INR (TIME Inr)
Time frame: postoperative day 7 assessment
Prolonged (>Seven Days) Time to Normalize Platelet Count (TIME Plt).
Time frame: postoperative day 7 assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Postoperative Graft Function
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Recruiting
Intramuscular Injection of Mashed Parathyroid Tissue Into a Forearm During Thyroid Surgery to Prevent Permanent Postoperative Parathyroid Insufficiency (IMIPAT Study)
Graft Function
Recruiting
The Impact of Intraoperative Diuretic Use on Delayed Graft Function Following Deceased Donor Renal Transplantation
Delayed Graft Function, Kidney Transplantation
Not yet recruiting
Flow-Controlled vs. Pressure-Controlled Ventilation in CABG: Effects on Lung Aeration and Diaphragm Function
Coronary Artery Disease, Postoperative Pulmonary Complications
Not yet recruiting
Effect of Discarding Initial Reperfusion Blood on Hemodynamics, Liver Function, and 30-Day Outcomes in Liver Transplantation
Liver Transplantation, Ischaemia Reperfusion Injury
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.
Yoshihisa Morita, MD principal investigator
Henry Ford Hospital
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 Postoperative Graft Function, run by Henry Ford Health System 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 1 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 23 Sep 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?
Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
EAD (time frame: EAD met at any point within the first 7 days status post OLT). 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 23 Sep 2024.