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

NCT03814031 | Completed Results

• 1 other identifier: 12156
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Graft Function

Keywords

TEE; orthotopic liver transplant; EAD

Outcome Measures

Primary Outcomes (1)

• EAD

  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.

  EAD met at any point within the first 7 days status post OLT

Secondary Outcomes (4)

• Acute Rejection

  Acute rejection noted at any point within 6-8 weeks post transplant

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

  postoperative day 7 assessment

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

  postoperative day 7 assessment

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

  postoperative day 7 assessment

Study Arms (2)

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.

Other: NO internvention

No EAD after orthotopic liver transplantation

No EAD

Other: NO internvention

Interventions

NO internvention OTHER

NO internvention

EAD after orthotopic liver transplantation; No EAD after orthotopic liver transplantation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

OLT with piggy back technique

You may qualify if:

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

You may not qualify if:

• TEE absolute contraindication patient refusal

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

HFHS

Detroit, Michigan, 48202, United States

Location

Results Point of Contact

• Title: Yoshihisa Morita
• Organization: Henry Ford Hospital

YOSHIHISA.MORITA@JEFFERSON.EDU

3059784358

Study Officials

• Yoshihisa Morita, MD

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 23, 2019
• Study Start: February 20, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)