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

Completed

• Conditions: Postoperative Graft Function
• Interventions: Other: NO internvention

• Registration Number: NCT03814031
• Lead Sponsor: Henry Ford Health System

Brief 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 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 Timeline

• Study Start: 2018-02-20
• Study First Submitted: 2019-01-16
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-23
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

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

Exclusion Criteria

TEE absolute contraindication patient refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EAD after orthotopic liver transplantation	NO internvention	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 internvention	No EAD

Primary Outcome Measures

Name	Time	Method
EAD	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.

Secondary Outcome Measures

Name	Time	Method
Acute Rejection	Acute rejection noted at any point within 6-8 weeks post transplant	Acute rejection noted with biopsy at any point within 6 to 8 weeks post-transplant
Prolonged (>Seven Days) Time to Normalize Total Bilirubin (TIME T-bil)	postoperative day 7 assessment	Normal total bilirubin \< 1.2 mg/dL
Prolonged (>Seven Days) Time to Normalize INR (TIME Inr)	postoperative day 7 assessment	Normal INR \< 1.16
Prolonged (>Seven Days) Time to Normalize Platelet Count (TIME Plt).	postoperative day 7 assessment	Normal platelet count \> 140 B/L

Trial Locations

Locations (1)

HFHS; 🇺🇸 Detroit, Michigan, United States