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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| No EAD after orthotopic liver transplantation | No EAD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NO internvention | Other | NO internvention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | EAD met at any point within the first 7 days status post OLT |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Rejection | Acute rejection noted with biopsy at any point within 6 to 8 weeks post-transplant | Acute rejection noted at any point within 6-8 weeks post transplant |
| Prolonged (>Seven Days) Time to Normalize Total Bilirubin (TIME T-bil) |
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Inclusion Criteria:
Orthotopic liver transplants which uses TEE intraoperatively Must be Piggy back technique
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Exclusion Criteria:
TEE absolute contraindication patient refusal
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OLT with piggy back technique
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| Name | Affiliation | Role |
|---|---|---|
| Yoshihisa Morita, MD | Henry Ford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HFHS | Detroit | Michigan | 48202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. NO intervention |
| FG001 | No EAD After Orthotopic Liver Transplantation | No EAD noted after orthotopic liver transplantation NO intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Of 120 potentially eligible patients, 97 patients participated in the study (patient refusal to participate in the study: 2 cases, absolute TEE contraindication: 5 cases, damping of the HVs images: 6 cases, and technically challenging to obtain appropriate views for HVF measurement: 10 cases).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. NO intervention |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | 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. | Posted | Median | Inter-Quartile Range | L/kg/min | EAD met at any point within the first 7 days status post OLT |
|
3 months postoperatively
No research related adverse events occurred. Since this is additional measurement of hepatic vein flow using existing TEE, no adverse events were anticipated or occurred.
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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 | 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. NO internvention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yoshihisa Morita | Henry Ford Hospital | 3059784358 | YOSHIHISA.MORITA@JEFFERSON.EDU |
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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 | Mar 18, 2019 | Oct 23, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 18, 2019 | Oct 22, 2023 | ICF_001.pdf |
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Normal total bilirubin < 1.2 mg/dL
| postoperative day 7 assessment |
| Prolonged (>Seven Days) Time to Normalize INR (TIME Inr) | Normal INR < 1.16 | postoperative day 7 assessment |
| Prolonged (>Seven Days) Time to Normalize Platelet Count (TIME Plt). | Normal platelet count > 140 B/L | postoperative day 7 assessment |
| No EAD After Orthotopic Liver Transplantation |
No EAD noted after orthotopic liver transplantation NO intervention |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| No EAD After Orthotopic Liver Transplantation |
No EAD noted after orthotopic liver transplantation NO intervention |
|
|
| Secondary | Acute Rejection | Acute rejection noted with biopsy at any point within 6 to 8 weeks post-transplant | Adult patients undergoing the orthotopic liver transplant piggy-back technique with TEE-measured HV flow | Posted | Median | Inter-Quartile Range | L/kg/min | Acute rejection noted at any point within 6-8 weeks post transplant |
|
|
|
| Secondary | Prolonged (>Seven Days) Time to Normalize Total Bilirubin (TIME T-bil) | Normal total bilirubin < 1.2 mg/dL | Adult patients undergoing the orthotopic liver transplant piggy-back technique with TEE-measured HV flow | Posted | Median | Inter-Quartile Range | L/kg/min | postoperative day 7 assessment |
|
|
|
| Secondary | Prolonged (>Seven Days) Time to Normalize INR (TIME Inr) | Normal INR < 1.16 | Adult patients undergoing the orthotopic liver transplant piggy-back technique with TEE-measured HV flow | Posted | Median | Inter-Quartile Range | L/kg/min | postoperative day 7 assessment |
|
|
|
| Secondary | Prolonged (>Seven Days) Time to Normalize Platelet Count (TIME Plt). | Normal platelet count > 140 B/L | Adult patients undergoing the orthotopic liver transplant piggy-back technique with TEE-measured HV flow | Posted | Median | Inter-Quartile Range | L/kg/min | postoperative day 7 assessment |
|
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| Post-Hoc | Intra-rater Reliability Analyses of HVFi | Intra-rater and inter-rater reliability analyses of HVFi are performed using intraclass correlation coefficient (ICC). We randomly pick up 30 images and obtain consistency ICC for inter-observer variability using all three investigators (A, B, and C), and absolute-agreement ICC for intra-observer variability using investigator C, who measure all images twice with an interval between 6 and 8 weeks. For inter-observer variability, 3 investigators post-hoc determine HVFi based on the pulse-wave Doppler signal. | Randomly chosen 30 patients among enrolled patients | Posted | Median | 95% Confidence Interval | ICC | Timing is postoperatively at any point 6-8 weeks. Duration is a day. |
|
|
|
| Post-Hoc | Inter-rater Reliability Analyses of HVFi | Intra-rater and inter-rater reliability analyses of HVFi are performed using intraclass correlation coefficient (ICC). We randomly pick up 30 images and obtain consistency ICC for inter-observer variability using all three investigators (A, B, and C). For inter-observer variability, 3 investigators post-hoc determine HVFi based on the pulse-wave Doppler signal. | Randomly chosen 30 patients among enrolled patients | Posted | Mean | 95% Confidence Interval | ICC | Timing is postoperative at any point. Duration is a day. |
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|
| 0 |
| 21 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | No EAD After Orthotopic Liver Transplantation | No EAD group. NO intervention | 0 | 76 | 0 | 71 | 0 | 71 |
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