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

NCT ID: NCT03814031

Last Updated: 2024-09-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-20

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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

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Postoperative Graft Function

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Intervention Type OTHER

NO internvention

No EAD after orthotopic liver transplantation

No EAD

NO internvention

Intervention Type OTHER

NO internvention

Interventions

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NO internvention

NO internvention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

\-

Exclusion Criteria

TEE absolute contraindication patient refusal
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Yoshihisa Morita

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoshihisa Morita, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Hospital

Locations

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HFHS

Detroit, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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12156

Identifier Type: -

Identifier Source: org_study_id

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