Liver Transplant; ComplicationsNCT04104971
Complications of Pediatric Liver Transplantation
An observational study of Liver Transplant; Complications, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Liver Transplant; Complications
- What is being tested?
- blood tests , abdominal US and doppler
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Any patient who did not survive beyond the first post operative day.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Children Hospital
Asyut
Ahmed MN Mohamed, MD, 01066778077 ext. 02, elhomosany2020@yahoo.com
About this study
Official title: Early and Late Complications of Living Related Pediatric Liver Transplantation
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.
Read the detailed description
Liver transplant is the treatment of choice in children with end-stage liver failure. It involves the surgical removal of the entire organ, which is then replaced with a healthy donor liver. Having a healthy liver is essential to longevity because the liver is responsible for nutrient distribution and toxin removal in the body .
Living-donor liver transplantation has been developed to address the disparity between the number candidates for transplant and the reduced number of available organs for liver transplantation.
In general, liver transplant (LT) is indicated when the risk of mortality from the native liver disease outweighs the overall risk of transplantation. Indications for liver transplantation in children include malignant and non-malignant conditions.
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
- Being tested
- blood tests , abdominal US and doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood tests , abdominal US and dopplerDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| with complications | children who did liver transplantation and develop complications Receives: Diagnostic Test: blood tests , abdominal US and doppler | |
| without complications | children who did liver transplantation and do not develop complications Receives: Diagnostic Test: blood tests , abdominal US and doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study startJan 2015
- Primary completionMar 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Najeb Mohamed, Assiut University
- Investigators
- Naglaa HI Abu.Faddan, prof, Study director, Assiut university children hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104971
- Sponsor's protocol ID
- liver transplantation
- Status last verified
- Sep 2019
- First submitted
- 24 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: there is a plan to make IPD and related data dictionaries available
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and Late Complications of Living Related Pediatric Liver Transplantation
- ClinicalTrials.gov ID
- NCT04104971
- Acronym / sponsor ID
- liver transplantation
- Conditions
- Liver Transplant; Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Liver transplant is the treatment of choice in children with end-stage liver failure. It involves the surgical removal of the entire organ, which is then replaced with a healthy donor liver. Having a healthy liver is essential to longevity because the liver is responsible for nutrient distribution and toxin removal in the body .
Living-donor liver transplantation has been developed to address the disparity between the number candidates for transplant and the reduced number of available organs for liver transplantation.
In general, liver transplant (LT) is indicated when the risk of mortality from the native liver disease outweighs the overall risk of transplantation. Indications for liver transplantation in children include malignant and non-malignant conditions.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with complications | – | Diagnostic Test: blood tests , abdominal US and dopplerchildren who did liver transplantation and develop complications |
| without complications | – | Diagnostic Test: blood tests , abdominal US and dopplerchildren who did liver transplantation and do not develop complications |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Any patient who did not survive beyond the first post operative day.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood tests , abdominal US and doppler | Diagnostic test | with complications, without complications |
Primary outcome
hematological ,vascular and infectious complications
Time frame: 5 years
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Results publicationReuben 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.
- Individual participant dataSharing planned: Yes. there is a plan to make IPD and related data dictionaries available
Related trials for Liver Transplant; Complications
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Active, not recruitingPhase 2
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
Mucopolysaccharidosis Disorders, Hurler Syndrome
Recruiting
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
Liver Transplantation (LT), Ischemia-Reperfusion Injury
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Not yet recruiting
Prophylactic Norepinephrine for Prevention of Acute Kidney Injury in Living-Donor Liver Transplantation
Noradrenaline
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naglaa HI Abu.Faddan, prof study director
Assiut university children hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant; Complications, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed MN Mohamed, MD (01066778077 ext. 02, elhomosany2020@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hematological ,vascular and infectious complications (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04104971, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.