Complications of Pediatric Liver Transplantation

NCT04104971 | Unknown

• 1 other identifier: liver transplantation
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Liver transplant is the treatment of choice in children with end-stage liver failure.liver transplant is indicated when the risk of mortality from the native liver disease outweighs the overall risk of transplantation.The complications occur both immediately post-transplantation and in the long-term. The main complications in the immediate postoperative period are related to the function of the graft (dysfunction and rejection), the surgical technique, infections (bacterial, fungal, and viral),and systemic problems (pulmonary, renal, or neurological) and in the long term, the complications are typically a consequence of the prolonged immunosuppressive therapy.

Conditions

Liver Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• hematological ,vascular and infectious complications

  Number of patients have vascular complications Number of patients have pancytopenia Number of patients have bacterial viral or fungal infection any changes in septic screen of the patient

  5 years

Study Arms (2)

with complications

children who did liver transplantation and develop complications

Diagnostic Test: blood tests , abdominal US and doppler

without complications

children who did liver transplantation and do not develop complications

Diagnostic Test: blood tests , abdominal US and doppler

Interventions

blood tests , abdominal US and doppler DIAGNOSTIC_TEST

with complications; without complications

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

children who were prepared for liver transplantation and followed up at Yassin Abdel Ghaffar charity center for liver disease and research,Cairo,Egypt.

You may qualify if:

• All patients from (1- 18) years old who were prepared for liver transplantation and followed up at Yassin Abdel Ghaffar charity center for liver disease and research,Cairo,Egypt. from January 2015 to the end of March 2020.

You may not qualify if:

• Any patient who did not survive beyond the first post operative day.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Children Hospital

Asyut, Egypt

RECRUITING

Related Publications (1)

• Reuben A. Long-term management of the liver transplant patient: diabetes, hyperlipidemia, and obesity. Liver Transpl 2001; 7(Suppl 1): S13-21. Bucuvalas, J., Long-term outcomes in pediatric liver transplantation. Liver Transpl, 2009. 15Suppl 2: p. S6-11. Seyfert-Margolis, V. and S. Feng, Tolerance: is it achievable in pediatric solid organ transplantation? Pediatr Clin North Am, 2010. 57(2): p. 523-38, table of contents. Hackl, C., et al., Current developments in pediatric liver transplantation. World J Hepatol, 2015.7(11): p. 1509-20.

  RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

* complete blood count and differential count * C-reactive protein , CMV and EBV serology, Liver function ,abdominal Us ,hepatitis markers (A,B ,C ) ,Galactomannan for fungal infection, chest x ray and CT chest. * Vascular complications by: Doppler showing (graft size and echopattern ,portal vein, pre and post anastomosis, hepatic veins , biliary passages and hepatic artery resistive index ) and abdominal US .

MeSH Terms

Interventions

Hematologic Tests; Echocardiography, Doppler

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography; Ultrasonography, Doppler; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Naglaa HI Abu.Faddan, prof

  Assiut university children hospital

  STUDY DIRECTOR

Central Study Contacts

Ahmed MN Mohamed, MD

CONTACT

01066778077; elhomosany2020@yahoo.com

Enas M Sayed, MD

CONTACT

01004870406; enasmhmd05@gmail.com

Study Design

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

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: January 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2021
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting at march 2020
• Access Criteria: through finding the research in the site of ClinicalTrials.gov

Locations

EG (1)