Liver Transplant; ComplicationsSEPTIFOIENCT04302246
Immune Function Following Liver Transplantation
An observational study of Liver Transplant; Complications, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Post-operative care following liver transplantation is characterized by a high incidence of infective and immunological complications. Restauration of liver function following liver transplantation is progressive and characterize a period of immuno-infective vulnerability. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Liver Transplant; Complications
- What is being tested?
- Biological testing on sequential blood sample
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2016to 17 Dec 2019
- 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 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Child admitted for liver transplantation
Who may be able to join
- Child under 18 admitted for liver transplantation
- Signature of consent by the two holders of parental authority.
- Informing children as far as their age and condition allow.
- Affiliation to a social protection
Who cannot join
- Children under 6 kg
- Children transplanted for primary graft dysfunction
- Children scheduled for liver-kidney transplants
About this study
Official title: Immune Functional Profile as Predictor of Infective Complications Following Pediatric Liver Transplantation
Post-operative care following liver transplantation is characterized by a high incidence of infective and immunological complications. Restauration of liver function following liver transplantation is progressive and characterize a period of immuno-infective vulnerability. The purpose of this study is to characterize the early post-operative immune function in children after liver transplantation.
Read the detailed description
Within a few decades, liver transplantation has become an effective treatment of end-stage liver diseases associated with high spontaneous mortality. However, the consequences of immediate transplants are frequently complicated by infective (nosocomial infection) and immunological complications (acute graft rejection) in up to 40 to 60% of liver transplanted patients. In order to ensure graft immunotolerance, immunosuppressive therapy based mainly on calcineurin inhibitors, is initiated soon after liver transplantation. Immunosuppressive therapy is intended to reduce the response of cytotoxic lymphocytes and NK cells. As a result, an important component of the immune response is blocked. In addition, function of the transplanted liver, which is a key organ for both immuno-inflammatory signalling and host defense against pathogens, is progressively restored post-operatively. Thus in this post-transplant period, there is a critical period where liver function is severly impaired and progressively get restaured. The aim of this study is to characterize the restauration of immune function in the early post-operative period and evaluate its correlation with occurence of infective or immunological complications.
- Conditions
- Liver Transplant; Complications
- Being tested
- Biological testing on sequential blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological testing on sequential blood sampleGenetic
Biological characterization of various immune function and blood circulating leukocytes phenotyping before liver transplantation and therafter at day-3, -7, -14 postoperatively and if septic complication occurs.
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune functionnal profile
quantitative monocytes mHLA-DR measurment
Measured: pre-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start8 Jan 2016
- Primary completion17 Dec 2019
- Study completion17 Dec 2019
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre TISSIERES, Principal investigator, Assistance Publique des Hopitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302246
- Sponsor's protocol ID
- NI 11055
- Acronym
- SEPTIFOIE
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2019
- Last updated
- 10 Mar 2020
- 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 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Functional Profile as Predictor of Infective Complications Following Pediatric Liver Transplantation
- ClinicalTrials.gov ID
- NCT04302246
- Acronym / sponsor ID
- SEPTIFOIE / NI 11055
- Conditions
- Liver Transplant; Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Jan 2016
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 10 Mar 2020 (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.
Post-operative care following liver transplantation is characterized by a high incidence of infective and immunological complications. Restauration of liver function following liver transplantation is progressive and characterize a period of immuno-infective vulnerability. The purpose of this study is to characterize the early post-operative immune function in children after liver transplantation.
Detailed description
Within a few decades, liver transplantation has become an effective treatment of end-stage liver diseases associated with high spontaneous mortality. However, the consequences of immediate transplants are frequently complicated by infective (nosocomial infection) and immunological complications (acute graft rejection) in up to 40 to 60% of liver transplanted patients. In order to ensure graft immunotolerance, immunosuppressive therapy based mainly on calcineurin inhibitors, is initiated soon after liver transplantation. Immunosuppressive therapy is intended to reduce the response of cytotoxic lymphocytes and NK cells. As a result, an important component of the immune response is blocked. In addition, function of the transplanted liver, which is a key organ for both immuno-inflammatory signalling and host defense against pathogens, is progressively restored post-operatively. Thus in this post-transplant period, there is a critical period where liver function is severly impaired and progressively get restaured. The aim of this study is to characterize the restauration of immune function in the early post-operative period and evaluate its correlation with occurence of infective or immunological complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Child admitted for liver transplantation
Key inclusion criteria (4 listed)
- Child under 18 admitted for liver transplantation
- Signature of consent by the two holders of parental authority.
- Informing children as far as their age and condition allow.
- Affiliation to a social protection
Key exclusion criteria (3 listed)
- Children under 6 kg
- Children transplanted for primary graft dysfunction
- Children scheduled for liver-kidney transplants
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 |
|---|---|---|
| Biological testing on sequential blood sampleBiological characterization of various immune function and blood circulating leukocytes phenotyping before liver transplantation and therafter at day-3, -7, -14 postoperatively and if septic complication occurs. | Genetic | – |
Primary outcome
Immune functionnal profile
Time frame: pre-operatively
quantitative monocytes mHLA-DR measurment
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 10 Mar 2020.
- 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.
Pierre TISSIERES principal investigator
Assistance Publique des Hopitaux de Paris
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant; Complications, run by Assistance Publique - Hôpitaux de Paris.
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 4 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 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Immune functionnal profile (time frame: pre-operatively). 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 10 Mar 2020.