Liver and Biliary Tract Disorders in Duration of PregnancyNCT06045949
Prediction of Early Recovery of Liver Function After LDLT in Children: An Ambispective Cohort Study
An observational study of Liver and Biliary Tract Disorders in Duration of Pregnancy and Other End-stage Liver Diseases in Children, run by Huiwu Xing at 1 site in China.
Trial summary
The investigators included children with living donor liver transplantation (LDLT) from January 1, 2018 to July 31, 2022 as a retrospective cohort, and the group from August 1, 2022 to June 30, 2023 as a prospective cohort. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Liver and Biliary Tract Disorders in Duration of Pregnancy, Other End-stage Liver Diseases in Children
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2022to 1 Sep 2023
- How long will I take part?
- 30 Days
- 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 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The investigators included children who underwent LDLT in this center from January 1, 2018 to June 30, 2023.
Who may be able to join
- children with the indication of LDLT [cholestatic liver disease (such as BA), metabolic liver disease (such as Wilson's disease and Ornithine transcarbamylase deficiency), acute liver failure (such as drug induced), neoplastic disease (such as hepatoblastoma), vascular disease (such as cavernous transformation of portal vein and congenital absence of portal vein), re-transplantation and others];
- the relatives of the children voluntarily donated part of the liver which met the requirements of LDLT.
Who cannot join
- recipients with contraindications of LDLT (such as coagulation dysfunction, acute infection, cardiopulmonary failure);
- failure to complete LDLT due to various reasons (such as death during or within 3 days after operation);
- recipients or donors with incomplete necessary data.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
About this study
Official title: Prediction of Early Recovery of Liver Function After Living Donor Liver Transplantation in Children: An Ambispective Cohort Study
The investigators included children with living donor liver transplantation (LDLT) from January 1, 2018 to July 31, 2022 as a retrospective cohort, and the group from August 1, 2022 to June 30, 2023 as a prospective cohort. The investigators collected the demographic and clinicopathological data of donors and recipients, and determined the risk factors of early postoperative delayed recovery of hepatic function (DRHF) by univariate and multivariate Logical regression analyses.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| living donor liver transplantation in children | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
DRHF
Investigators collected liver function data of children after LDLT. Delayed recovery of hepatic function (DRHF) is characterized by the increase of PT-INR combined with hyperbilirubinemia on or after postoperative day 5.
Measured: 30 days after LDLT in children
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start31 Jul 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver and Biliary Tract Disorders in Duration of PregnancyStudies 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
- Other
- Enrolment
- 230 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Huiwu Xing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huiwu Xing, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045949
- Sponsor's protocol ID
- DRHFafterLDLT
- Status last verified
- Sep 2023
- First submitted
- 9 Sep 2023
- Last updated
- 21 Sep 2023
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Early Recovery of Liver Function After Living Donor Liver Transplantation in Children: An Ambispective Cohort Study
- ClinicalTrials.gov ID
- NCT06045949
- Acronym / sponsor ID
- DRHFafterLDLT
- Conditions
- Liver and Biliary Tract Disorders in Duration of Pregnancy, Other End-stage Liver Diseases in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Huiwu XingUniversity, hospital or other
- Study start
- 31 Jul 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 21 Sep 2023 (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 investigators included children with living donor liver transplantation (LDLT) from January 1, 2018 to July 31, 2022 as a retrospective cohort, and the group from August 1, 2022 to June 30, 2023 as a prospective cohort. The investigators collected the demographic and clinicopathological data of donors and recipients, and determined the risk factors of early postoperative delayed recovery of hepatic function (DRHF) by univariate and multivariate Logical regression analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| living donor liver transplantation in children | – | – |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The investigators included children who underwent LDLT in this center from January 1, 2018 to June 30, 2023.
Key inclusion criteria (2 listed)
- children with the indication of LDLT [cholestatic liver disease (such as BA), metabolic liver disease (such as Wilson's disease and Ornithine transcarbamylase deficiency), acute liver failure (such as drug induced), neoplastic disease (such as hepatoblastoma), vascular disease (such as cavernous transformation of portal vein and congenital absence of portal vein), re-transplantation and others];
- the relatives of the children voluntarily donated part of the liver which met the requirements of LDLT.
Key exclusion criteria (3 listed)
- recipients with contraindications of LDLT (such as coagulation dysfunction, acute infection, cardiopulmonary failure);
- failure to complete LDLT due to various reasons (such as death during or within 3 days after operation);
- recipients or donors with incomplete necessary data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DRHF
Time frame: 30 days after LDLT in children
Investigators collected liver function data of children after LDLT. Delayed recovery of hepatic function (DRHF) is characterized by the increase of PT-INR combined with hyperbilirubinemia on or after postoperative day 5.
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 21 Sep 2023.
- Individual participant dataSharing planned: No
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?
An observational study of Liver and Biliary Tract Disorders in Duration of Pregnancy and Other End-stage Liver Diseases in Children, run by Huiwu Xing at 1 site in China.
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 2 inclusion and 3 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 21 Sep 2023. 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 China. 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?
DRHF (time frame: 30 days after LDLT in children). 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 21 Sep 2023.