Hepatic Vein Flow During Orthotopic Liver Transplantation as Predictive Factor for Postoperative Graft Function

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Graft Function
• Intervention / Treatment: Other: NO internvention

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 Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • HFHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

OLT with piggy back technique

Description

Inclusion Criteria:

Orthotopic liver transplants which uses TEE intraoperatively Must be Piggy back technique

-

Exclusion Criteria:

TEE absolute contraindication patient refusal

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: NO internvention; NO internvention
No EAD after orthotopic liver transplantation; No EAD	Other: NO internvention; NO internvention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Yoshihisa Morita, MD, Henry Ford Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: January 16, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: May 19, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: TEE; orthotopic liver transplant; EAD
• Other Study ID Numbers: 12156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No