Liver Transplant; ComplicationsNCT04789213
Mortality, Morbidity and Risk Factors of Liver Retransplantation
An observational study of Liver Transplant; Complications and Liver Transplant Rejection, run by Memorial Bahçelievler Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the short and long term outcomes of living donor and deceased donor liver retransplantation. Bearing that in mind, the investigators will retrospectively analyze the files of patients whom underwent a liver retransplantation in Memorial Bahcelievler Hospital Organ Transplantation Center. Read more about this study
- Who is it for?
- Ages 0 months and older
- Conditions the study is for
- Liver Transplant; Complications, Liver Transplant Rejection, Liver Transplant Failure
- What is being tested?
- Liver Transplantation
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2021to 1 May 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 0 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with liver failure who underwent a second liver transplantation (i.e. re-transplantation)
Who may be able to join
- Having a liver retransplantation
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Memorial Bahçelievler Hospital
Istanbul, 34700
About this study
Official title: Comparison of Mortality, Morbidity and Risk Factors in Living- Donor and Deceased-Donor Liver Retransplantation
This study aims to compare the short and long term outcomes of living donor and deceased donor liver retransplantation. Bearing that in mind, the investigators will retrospectively analyze the files of patients whom underwent a liver retransplantation in Memorial Bahcelievler Hospital Organ Transplantation Center.
- Conditions
- Liver Transplant; Complications, Liver Transplant Rejection, Liver Transplant Failure, Liver Diseases, Liver Cirrhosis, Liver Failure
- Being tested
- Liver Transplantation
- Medical subject headings
- Liver Diseases, Liver Cirrhosis, Liver Failure, Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver TransplantationOther
Liver Transplantation
| Study group | Role | What they receive |
|---|---|---|
| Patients with Living Donor Liver Transplantation | Not described Receives: Other: Liver Transplantation | |
| Patients with Deceased Donor Liver Transplantation | Not described Receives: Other: Liver Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival ratio
Overall graft and patient survival ratio
Measured: 1 minutes
Secondary outcomes (3)
Morbidity
Postoperative complications such as septicemia, hepatic artery thrombosis etc.
Measured: 10 minutes
Peri-operative informations
Peri-operative informations such as blood loss during surgery
Measured: 15 minutes
Blood Test Results
Patients' blood test results specific to liver such as International Normalization Ratio
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start10 Mar 2021
- Primary completion15 Apr 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 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
- Investigators
- Kamil Yalçın Polat, Prof, Principal investigator, Memorial Bahçelievler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789213
- Sponsor's protocol ID
- MemorialBahcelievler1
- Status last verified
- Dec 2021
- First submitted
- 5 Mar 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- 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 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mortality, Morbidity and Risk Factors in Living- Donor and Deceased-Donor Liver Retransplantation
- ClinicalTrials.gov ID
- NCT04789213
- Acronym / sponsor ID
- MemorialBahcelievler1
- Conditions
- Liver Transplant; Complications, Liver Transplant Rejection, Liver Transplant Failure, Liver Diseases, Liver Cirrhosis, Liver Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Memorial Bahçelievler HospitalUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 9 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.
This study aims to compare the short and long term outcomes of living donor and deceased donor liver retransplantation. Bearing that in mind, the investigators will retrospectively analyze the files of patients whom underwent a liver retransplantation in Memorial Bahcelievler Hospital Organ Transplantation Center.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Living Donor Liver Transplantation | – | Other: Liver Transplantation |
| Patients with Deceased Donor Liver Transplantation | – | Other: Liver Transplantation |
Who may qualify
- Ages
- 0 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with liver failure who underwent a second liver transplantation (i.e. re-transplantation)
Key inclusion criteria (1 listed)
- Having a liver retransplantation
Key exclusion criteria (1 listed)
- N/A
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 | Other | Patients with Deceased Donor Liver Transplantation, Patients with Living Donor Liver Transplantation |
Primary outcome
Survival ratio
Time frame: 1 minutes
Overall graft and patient survival ratio
3 secondary outcomes
Morbidity
Time frame: 10 minutes
Peri-operative informations
Time frame: 15 minutes
Blood Test Results
Time frame: 20 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 Dec 2021.
- 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.
Kamil Yalçın Polat, Prof principal investigator
Memorial Bahçelievler 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 and Liver Transplant Rejection, 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 Dec 2021. 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 ratio (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 Dec 2021.