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Trial record 26 of 2660 for:    bilirubin

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

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ClinicalTrials.gov Identifier: NCT03814031
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Yoshihisa Morita, 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 prolonged total bilirubin level.

Condition or disease Intervention/treatment
Postoperative Graft Function Other: NO internvention

Detailed Description:
During OLT, intraoperative TEE assessment of HVF (systolic and diastolic), and indices of postoperative graft function including time to normalization of INR, platelet, and total bilirubin. HVF was calculated with hepatic vein area (cm2) x hepatic vein velocity (ml/s) in systole and diastole during the neohepatic phase. Investigators defined HVF index (HVFi) as: HVF/donor liver size (kg). Investigators did ROC analysis to assess the predictive power for prolonged INR, platelet, and total bilirubin.

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Study Type : Observational
Estimated Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hepatic Vein Flow Assessment With Transesophageal Echocardiography for Postoperative Graft Function Prediction in Orthotopic Liver Transplantation
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
postoperative prolonged total bilirubin
We will follow total bilirubin treat after orthotopic liver transplant, and include in this ARM if prolonged total bilirubin >7 days.
Other: NO internvention
NO internvention

postoperative NOT prolonged total bilirubin
We will follow total bilirubin treat after orthotopic liver transplant, and include in this ARM if prolonged total bilirubin <7 days.
Other: NO internvention
NO internvention




Primary Outcome Measures :
  1. prolonged total bilirubin >7 days [ Time Frame: 7 days status post OLT ]
    We will follow total bilirubin after OLT


Secondary Outcome Measures :
  1. early graft loss [ Time Frame: 6 weeks status post OLT ]
    graft loss within 6 weeks

  2. late graft loss [ Time Frame: 6 weeks status post OLT ]
    graft loss after more than 6 weeks



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
OLT with piggy back technique
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

TEE absolute contraindication patient refusal

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03814031


Contacts
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Contact: Yoshihisa Morita, MD 313-970-1282 ymorita1@hfhs.org
Contact: Ahmad Itani, DO 313-704-8451 aitani1@hfhs.org

Locations
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United States, Michigan
HFHS Recruiting
Detroit, Michigan, United States, 48202
Contact: Kelly Jones    313-874-4420    kjones1@hfhs.org   
Sponsors and Collaborators
Henry Ford Health System

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Responsible Party: Yoshihisa Morita, MD, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03814031     History of Changes
Other Study ID Numbers: 12156
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yoshihisa Morita, Henry Ford Health System:
TEE
orthotopic liver transplant
postoperative graft function

Additional relevant MeSH terms:
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Bilirubin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs