Investigation of Mortality, Morbidity and Risk Factors After Pediatric Liver Transplantation

Investigation of Mortality, Morbidity and Risk Factors After Pediatric Liver Transplantation: A Retrospective Study

The Department of Organ Transplantation in Memorial Hospitals has started Pediatric Liver Transplantation Program in 2016. As of the end of 2020, we have performed 169 pediatric liver transplantation. The aim of this study is to investigate the overall mortality, morbidity and risk factors for adverse outcomes in pediatric liver transplantation. The patients' records will be retrospectively scanned and the data will be gathered.

Study Overview

• Status: Completed
• Conditions: Liver Diseases; Liver Transplantation; Mortality; Biliary Atresia; Morbidity;Infant
• Intervention / Treatment: Procedure: Liver Transplantation

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34700
    • Memorial Bahcelievler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pediatric patients with liver transplantation (<18 years)

Exclusion Criteria:

• Patients with incomplete medical records will be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Pediatric Patients with Liver Transplantation	Procedure: Liver Transplantation; Liver Transplantation is performed under spesific conditions to increase the life time of patients with liver diseases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Patient and graft survival ratios	1 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative informations	Perioperative informations such as blood loss and blood transfusion	5 minutes
Blood Tests	Blood markers that evaluated at the pre and post operative phase such as Internation Normalized Ratio (INR), total bilirubin and albumin values.	15 minutes
Postoperative Complications	Postoperative Complications such as sepsis or hepatic artery thrombosis	5 minutes
Postoperative informations	Postoperative informations such as initial hospital stay, ICU stay or mechanic ventilation time	10 minutes

Collaborators and Investigators

• Sponsor: Memorial Bahçelievler Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 24, 2021
• Primary Completion (ACTUAL): April 1, 2022
• Study Completion (ACTUAL): April 4, 2022

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 28, 2021
• First Posted (ACTUAL): March 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Biliary Tract Diseases; Bile Duct Diseases; Digestive System Abnormalities; Liver Diseases; Biliary Atresia
• Other Study ID Numbers: MemorialBahcelievler

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No