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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

Tracking Information
First Submitted Date January 16, 2019
First Posted Date January 23, 2019
Last Update Posted Date January 23, 2019
Actual Study Start Date February 20, 2018
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2019)
prolonged total bilirubin >7 days [ Time Frame: 7 days status post OLT ]
We will follow total bilirubin after OLT
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 22, 2019)
  • early graft loss [ Time Frame: 6 weeks status post OLT ]
    graft loss within 6 weeks
  • late graft loss [ Time Frame: 6 weeks status post OLT ]
    graft loss after more than 6 weeks
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hepatic Vein Flow During Orthotopic Liver Transplantation as Predictive Factor for Postoperative Graft Function
Official Title Hepatic Vein Flow Assessment With Transesophageal Echocardiography for Postoperative Graft Function Prediction in Orthotopic Liver Transplantation
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population OLT with piggy back technique
Condition Postoperative Graft Function
Intervention Other: NO internvention
NO internvention
Study Groups/Cohorts
  • 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.
    Intervention: Other: 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.
    Intervention: Other: NO internvention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 22, 2019)
62
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

TEE absolute contraindication patient refusal

-

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Yoshihisa Morita, MD 313-970-1282 ymorita1@hfhs.org
Contact: Ahmad Itani, DO 313-704-8451 aitani1@hfhs.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03814031
Other Study ID Numbers 12156
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Yoshihisa Morita, Henry Ford Health System
Study Sponsor Henry Ford Health System
Collaborators Not Provided
Investigators Not Provided
PRS Account Henry Ford Health System
Verification Date January 2019