Back to resultsInvestigation of Mortality, Morbidity and Risk Factors After Pediatric Liver Transplantation
Primary Purpose
Liver Transplantation, Liver Diseases, Biliary Atresia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Liver Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Liver Transplantation
Eligibility Criteria
Inclusion Criteria:
- Pediatric patients with liver transplantation (<18 years)
Exclusion Criteria:
- Patients with incomplete medical records will be excluded
Sites / Locations
- Memorial Bahçelievler Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pediatric Patients with Liver Transplantation
Arm Description
Outcomes
Primary Outcome Measures
Survival
Patient and graft survival ratios
Secondary Outcome Measures
Perioperative informations
Perioperative informations such as blood loss and blood transfusion
Blood Tests
Blood markers that evaluated at the pre and post operative phase such as Internation Normalized Ratio (INR), total bilirubin and albumin values.
Postoperative Complications
Postoperative Complications such as sepsis or hepatic artery thrombosis
Postoperative informations
Postoperative informations such as initial hospital stay, ICU stay or mechanic ventilation time
Full Information
NCT ID
NCT04778735
First Posted
February 24, 2021
Last Updated
April 4, 2022
Sponsor
Memorial Bahçelievler Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04778735
Brief Title
Investigation of Mortality, Morbidity and Risk Factors After Pediatric Liver Transplantation
Official Title
Investigation of Mortality, Morbidity and Risk Factors After Pediatric Liver Transplantation: A Retrospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memorial Bahçelievler Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Liver Diseases, Biliary Atresia, Morbidity;Infant, Mortality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pediatric Patients with Liver Transplantation
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Liver Transplantation
Intervention Description
Liver Transplantation is performed under spesific conditions to increase the life time of patients with liver diseases.
Primary Outcome Measure Information:
Title
Survival
Description
Patient and graft survival ratios
Time Frame
1 minutes
Secondary Outcome Measure Information:
Title
Perioperative informations
Description
Perioperative informations such as blood loss and blood transfusion
Time Frame
5 minutes
Title
Blood Tests
Description
Blood markers that evaluated at the pre and post operative phase such as Internation Normalized Ratio (INR), total bilirubin and albumin values.
Time Frame
15 minutes
Title
Postoperative Complications
Description
Postoperative Complications such as sepsis or hepatic artery thrombosis
Time Frame
5 minutes
Title
Postoperative informations
Description
Postoperative informations such as initial hospital stay, ICU stay or mechanic ventilation time
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pediatric patients with liver transplantation (<18 years)
Exclusion Criteria:
Patients with incomplete medical records will be excluded
Facility Information:
Facility Name
Memorial Bahçelievler Hospital
City
Istanbul
ZIP/Postal Code
34700
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigation of Mortality, Morbidity and Risk Factors After Pediatric Liver Transplantation
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