Liver Transplant DisorderIPRANCT05625139
Implementation of an Enhanced Rehabilitation Protocol After Liver Transplantation: Feasibility and Analysis of Results
An observational study of Liver Transplant Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Currently, there are no expert recommendations regarding enhanced rehabilitation after liver transplantation. The development of Enhanced Rehabilitation After Surgery (ERAS) protocols in major surgery, particularly cardiothoracic surgery, has motivated some anesthesia teams to extubate liver transplant patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Disorder
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2020to 14 Nov 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Major subject operated at HUS for a liver transplant whose management was scheduled in the Surgical Intensive Care Unit fbetween December 01, 2018 and August 31, 2020
Who may be able to join
- Major subject operated at HUS for a liver transplant whose management was scheduled in the Surgical Intensive Care Unit fbetween December 01, 2018 and August 31, 2020
- Subject who does not question, after information, the reuse of his data for the purpose of this research
Who cannot join
- Subject having expressed his opposition to participate in the study
- Liver transplant patient hospitalized in the Medical Intensive Care Unit before or after the surgery
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Anesthésie, Réanimation et Médecine péri-Opératoire - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Currently, there are no expert recommendations regarding enhanced rehabilitation after liver transplantation. The development of Enhanced Rehabilitation After Surgery (ERAS) protocols in major surgery, particularly cardiothoracic surgery, has motivated some anesthesia teams to extubate liver transplant patients earlier who meet predefined criteria (young patient, absence of comorbidities, absence of intraoperative transfusion) in order to limit the occurrence of complications of mechanical ventilation (pneumopathies, tracheal wound, muscle loss, etc.) On the other hand, improved rehabilitation in this case was often synonymous with early extubation in the operating room. Few studies, on the other hand, relate the implementation of a complete rehabilitation protocol including pre-, intra- and postoperative guidelines.
- Conditions
- Liver Transplant Disorder
- Keywords
- Liver Transplant Disorder, Liver transplantation, ERAS
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective description of the protocol of improved rehabilitation after liver transplantation, to study the possibility of its implementation in the anesthesia-intensive care department and to analyze the first results
Measured: Files analysed retrospectively from December 01, 2018 to August 31, 2020 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start14 Sep 2020
- Primary completion14 Sep 2021
- Study completion14 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625139
- Sponsor's protocol ID
- 7906
- Acronym
- IPRA
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Enhanced Rehabilitation Protocol After Liver Transplantation: Feasibility and Analysis of Results
- ClinicalTrials.gov ID
- NCT05625139
- Acronym / sponsor ID
- IPRA / 7906
- Conditions
- Liver Transplant Disorder
- Keywords
- Liver Transplant Disorder, Liver transplantation, ERAS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 14 Nov 2021 (actual)
- First posted
- 22 Nov 2022 (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.
Currently, there are no expert recommendations regarding enhanced rehabilitation after liver transplantation. The development of Enhanced Rehabilitation After Surgery (ERAS) protocols in major surgery, particularly cardiothoracic surgery, has motivated some anesthesia teams to extubate liver transplant patients earlier who meet predefined criteria (young patient, absence of comorbidities, absence of intraoperative transfusion) in order to limit the occurrence of complications of mechanical ventilation (pneumopathies, tracheal wound, muscle loss, etc.) On the other hand, improved rehabilitation in this case was often synonymous with early extubation in the operating room. Few studies, on the other hand, relate the implementation of a complete rehabilitation protocol including pre-, intra- and postoperative guidelines.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject operated at HUS for a liver transplant whose management was scheduled in the Surgical Intensive Care Unit fbetween December 01, 2018 and August 31, 2020
Key inclusion criteria (2 listed)
- Major subject operated at HUS for a liver transplant whose management was scheduled in the Surgical Intensive Care Unit fbetween December 01, 2018 and August 31, 2020
- Subject who does not question, after information, the reuse of his data for the purpose of this research
Key exclusion criteria (2 listed)
- Subject having expressed his opposition to participate in the study
- Liver transplant patient hospitalized in the Medical Intensive Care Unit before or after the surgery
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
Retrospective description of the protocol of improved rehabilitation after liver transplantation, to study the possibility of its implementation in the anesthesia-intensive care department and to analyze the first results
Time frame: Files analysed retrospectively from December 01, 2018 to August 31, 2020 will be examined
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 31 Oct 2023.
Related trials for Liver Transplant Disorder
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
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
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
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 Transplant Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
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 2 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 31 Oct 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 France. 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?
Retrospective description of the protocol of improved rehabilitation after liver transplantation, to study the possibility of its implementation in the anesthesia-intensive care department and to analyze the first results (time frame: Files analysed retrospectively from December 01, 2018 to August 31, 2020 will be examined). 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 31 Oct 2023.