Liver TransplantationRAC-THNCT03976765
Interest of an Early Rehabilitation Program in Liver Transplant Surgery
An observational study of Liver Transplantation, run by Rennes University Hospital at 1 site in France.
Trial summary
Monocentric, prospective study to evaluate 10 liver transplanted patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Rehabilitation program
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2018to 11 Aug 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Liver transplant patients
Who may be able to join
- Patient older than 18 years old
- First liver transplant
- Liver transplant alone
- MELD (Model for End stage Liver Disease) score ≤ 15
- CHILD-PUGH score ≤ 8 if cirrhosis
- Body Mass Index < 30 kg/m2
Show all 11Show fewer
- No history of transplant nor immunosuppression
- Absence of ascites nor hydrothorax drain
- Absence of treatment for diabetes
- Absence of renal insufficiency (glomerular filtration flow > 60 mL/min)
- Family help at home
Who cannot join
- Cold ischemia time > 8 hours
- Grafts from type III Maastricht
- Super urgent liver transplantation
- Perioperative blood transfusion > 4 packed red blood cells and/or 3 fresh frozen plasma
- Arterial anastomosis in splenic artery, in aorta or in coeliac artery
- Bilio-digestive anastomosis
- Persons deprived of liberty
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Rehabilitation Program in Liver Transplant Surgery: Hospital Discharge at Day 7 in a Targeted Population
Monocentric, prospective study to evaluate 10 liver transplanted patients
Read the detailed description
The improvement of perioperative technics and the prevention of complications with immunosuppression allowed for the development with success of liver transplant. 1322 liver transplants occurred in 2016 in France to 806 in 2000. Centre Hospitalier Universitaire (CHU) of Rennes became a reference with 122 liver transplants in 2016 being the second liver transplant center in France.
Early rehabilitation concept is a multidisciplinary approach (surgical, anesthetic…) that aims to reduce the length of hospital stay and peri operative morbidity/mortality. These programs have first been developed in colorectal surgery before extending to complicated surgery like cephalic duodeno-pancreatectomy or hepatectomy. There are poor data in the literature on early rehabilitation program in liver transplant.
- Conditions
- Liver Transplantation
- Being tested
- Rehabilitation program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation programOther
The patients follow different rehabilitation programs (surgery, anesthetic, post-operative). Hospital discharge is authorized only after validation of objective, clinical and para clinic criteria
| Study group | Role | What they receive |
|---|---|---|
| Hospital discharge at day 7 | Not described Receives: Other: Rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with an hospital discharge at day 7
Measured: Day 7
Secondary outcomes (5)
Number of patients readmission in the first month
Measured: Month 1
Number of days of hospitalization during the first month (post-surgery and prehospitalization)
Measured: Month 1
Number of death in the first month
Measured: Month 1
Satisfaction of the patient in the first month
Measured: Month 1
Number of surgery complications according to Dindo and Clavien classification during the first month
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start17 Dec 2018
- Primary completion11 Aug 2020
- Study completion11 Aug 2020
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.
- More trials run by Rennes University HospitalThe 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
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976765
- Sponsor's protocol ID
- 35RC18_9723_RAC-TH
- Acronym
- RAC-TH
- Status last verified
- Apr 2021
- First submitted
- 4 Jun 2019
- Last updated
- 15 Apr 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 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Rehabilitation Program in Liver Transplant Surgery: Hospital Discharge at Day 7 in a Targeted Population
- ClinicalTrials.gov ID
- NCT03976765
- Acronym / sponsor ID
- RAC-TH / 35RC18_9723_RAC-TH
- Conditions
- Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 11 Aug 2020 (actual)
- Study completion
- 11 Aug 2020 (actual)
- First posted
- 6 Jun 2019 (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.
Monocentric, prospective study to evaluate 10 liver transplanted patients
Detailed description
The improvement of perioperative technics and the prevention of complications with immunosuppression allowed for the development with success of liver transplant. 1322 liver transplants occurred in 2016 in France to 806 in 2000. Centre Hospitalier Universitaire (CHU) of Rennes became a reference with 122 liver transplants in 2016 being the second liver transplant center in France.
Early rehabilitation concept is a multidisciplinary approach (surgical, anesthetic…) that aims to reduce the length of hospital stay and peri operative morbidity/mortality. These programs have first been developed in colorectal surgery before extending to complicated surgery like cephalic duodeno-pancreatectomy or hepatectomy. There are poor data in the literature on early rehabilitation program in liver transplant.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospital discharge at day 7 | – | Other: Rehabilitation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver transplant patients
Key inclusion criteria (11 listed)
- Patient older than 18 years old
- First liver transplant
- Liver transplant alone
- MELD (Model for End stage Liver Disease) score ≤ 15
- CHILD-PUGH score ≤ 8 if cirrhosis
Key exclusion criteria (8 listed)
- Cold ischemia time > 8 hours
- Grafts from type III Maastricht
- Super urgent liver transplantation
- Perioperative blood transfusion > 4 packed red blood cells and/or 3 fresh frozen plasma
- Arterial anastomosis in splenic artery, in aorta or in coeliac artery
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 |
|---|---|---|
| Rehabilitation programThe patients follow different rehabilitation programs (surgery, anesthetic, post-operative). Hospital discharge is authorized only after validation of objective, clinical and para clinic criteria | Other | Hospital discharge at day 7 |
Primary outcome
Number of patients with an hospital discharge at day 7
Time frame: Day 7
5 secondary outcomes
Number of patients readmission in the first month
Time frame: Month 1
Number of days of hospitalization during the first month (post-surgery and prehospitalization)
Time frame: Month 1
Number of death in the first month
Time frame: Month 1
Satisfaction of the patient in the first month
Time frame: Month 1
Number of surgery complications according to Dindo and Clavien classification during the first month
Time frame: Month 1
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 15 Apr 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.
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 Transplantation, run by Rennes University Hospital 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 11 inclusion and 8 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 15 Apr 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 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?
Number of patients with an hospital discharge at day 7 (time frame: Day 7). 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 15 Apr 2021.