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OpenTrials
Completed

NCT Number: NCT03814031

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

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.

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Key information

Conditions

Postoperative Graft Function

Sex eligibility

All sexes

Study type

Observational

Primary location

HFHS

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

-

Exclusion criteria

TEE absolute contraindication patient refusal

Treatment and study plan

NO internvention

Other

NO internvention

Primary outcomes

  1. 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.

Secondary outcomes

  1. Acute Rejection

    Time frame: 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

  2. Prolonged (>Seven Days) Time to Normalize Total Bilirubin (TIME T-bil)

    Time frame: postoperative day 7 assessment

    Normal total bilirubin < 1.2 mg/dL

  3. Prolonged (>Seven Days) Time to Normalize INR (TIME Inr)

    Time frame: postoperative day 7 assessment

    Normal INR < 1.16

  4. Prolonged (>Seven Days) Time to Normalize Platelet Count (TIME Plt).

    Time frame: postoperative day 7 assessment

    Normal platelet count > 140 B/L

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

Hepatic Vein Flow Assessment With Transesophageal Echocardiography for Postoperative Graft Function Prediction in Orthotopic Liver Transplantation

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2019
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.