Interest of an Early Rehabilitation Program in Liver Transplant Surgery
RAC-TH
Early Rehabilitation Program in Liver Transplant Surgery: Hospital Discharge at Day 7 in a Targeted Population
1 other identifier
observational
10
1 country
1
Brief Summary
Monocentric, prospective study to evaluate 10 liver transplanted patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 17, 2018
CompletedFirst Submitted
Initial submission to the registry
June 4, 2019
CompletedFirst Posted
Study publicly available on registry
June 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2020
CompletedApril 15, 2021
April 1, 2021
1.7 years
June 4, 2019
April 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with an hospital discharge at day 7
Day 7
Secondary Outcomes (5)
Number of patients readmission in the first month
Month 1
Number of days of hospitalization during the first month (post-surgery and prehospitalization)
Month 1
Number of death in the first month
Month 1
Satisfaction of the patient in the first month
Month 1
Number of surgery complications according to Dindo and Clavien classification during the first month
Month 1
Study Arms (1)
Hospital discharge at day 7
Interventions
The patients follow different rehabilitation programs (surgery, anesthetic, post-operative). Hospital discharge is authorized only after validation of objective, clinical and para clinic criteria
Eligibility Criteria
Liver transplant patients
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Rennes
Rennes, 35033, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2019
First Posted
June 6, 2019
Study Start
December 17, 2018
Primary Completion
August 11, 2020
Study Completion
August 11, 2020
Last Updated
April 15, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share