Liver TransplantationNCT04778735
Investigation of Mortality, Morbidity and Risk Factors After Pediatric Liver Transplantation
A study testing Liver Transplantation in people with Liver Transplantation and Liver Diseases, run by Memorial Bahçelievler Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 months to 18 years
- Conditions the study is for
- Liver Transplantation, Liver Diseases, Biliary Atresia
- What is being tested?
- Liver Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2021to 4 Apr 2022
- Phase
- Interventional
- 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 0 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients with liver transplantation (<18 years)
Who cannot join
- Patients with incomplete medical records will be excluded
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Memorial Bahçelievler Hospital
Istanbul, 34700
About this study
Official title: 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.
- Being tested
- Liver Transplantation
- Medical subject headings
- Liver Diseases, Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver TransplantationProcedure or surgery
Liver Transplantation is performed under spesific conditions to increase the life time of patients with liver diseases.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Patients with Liver Transplantation | Other | Not described Receives: Procedure: Liver Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Patient and graft survival ratios
Measured: 1 minutes
Secondary outcomes (4)
Perioperative informations
Perioperative informations such as blood loss and blood transfusion
Measured: 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.
Measured: 15 minutes
Postoperative Complications
Postoperative Complications such as sepsis or hepatic artery thrombosis
Measured: 5 minutes
Postoperative informations
Postoperative informations such as initial hospital stay, ICU stay or mechanic ventilation time
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start24 Feb 2021
- Primary completion1 Apr 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Bahçelievler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamil Yalçın Polat, Memorial Bahçelievler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778735
- Sponsor's protocol ID
- MemorialBahcelievler
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Mortality, Morbidity and Risk Factors After Pediatric Liver Transplantation: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04778735
- Acronym / sponsor ID
- MemorialBahcelievler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Memorial Bahçelievler HospitalUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 3 Mar 2021 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Patients with Liver Transplantation | Other | Procedure: Liver Transplantation |
Who may qualify
- Ages
- 0 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric patients with liver transplantation (<18 years)
Key exclusion criteria (1 listed)
- Patients with incomplete medical records will be excluded
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 |
|---|---|---|
| Liver TransplantationLiver Transplantation is performed under spesific conditions to increase the life time of patients with liver diseases. | Procedure or surgery | Pediatric Patients with Liver Transplantation |
Primary outcome
Survival
Time frame: 1 minutes
Patient and graft survival ratios
4 secondary outcomes
Perioperative informations
Time frame: 5 minutes
Blood Tests
Time frame: 15 minutes
Postoperative Complications
Time frame: 5 minutes
Postoperative informations
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver Transplantation in people with Liver Transplantation and Liver Diseases, run by Memorial Bahçelievler Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 6 Apr 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 1 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2022.