NCT07777705

Brief Summary

the goal of this observational study is to apply different scores 1. To assess Fatigue, Frailty, Liver Transplant Comorbidity Index and MELD 3.0 in patients with liver cirrhosis awaiting liver transplantation. 2\. To evaluate the predictive accuracy of these Scores for the short-term outcomes (early complications, recurrent hospitalization and 3-month mortality). 3. To determine whether using these Scores in the pre-transplant evaluation improves risk stratification compared to MELD score alone.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 20, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

1.2 years

First QC Date

August 7, 2026

Last Update Submit

August 19, 2026

Conditions

Liver CirrhosisLiver Transplant

Keywords

cirrhosis and transplantationLiver cirrhosisLiver transplantation

Outcome Measures

Primary Outcomes (1)

  • Waitlist morbidity and Mortality of liver transplantation

    * Risk of early complications, rehospitalization and death while awaiting transplantation. 2\. Post-Transplant Survival for liver transplant recipients * 3- month survival (short-term outcome). Mortality hazard ratios associated with frailty, comorbidities, and MELD 3.0

    1.5 years

Eligibility Criteria

Age18 Years - 60 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

cirrhotic patients awaiting transplantation

You may qualify if:

  • All patients with liver cirrhosis (whatever the etiology) eligible for liver transplantation above the age of 18.
  • Written informed consent provided.

You may not qualify if:

  • Old age (above 60 years old)
  • Acute liver cell failure without underlying cirrhosis
  • Absolute contraindications (e.g., uncontrolled sepsis, severe cardiopulmonary dysfunction, active malignancy).
  • Extra-MELD indications (e.g., hepatopulmonary syndrome, refractory ascites, cholestatic pruritus, hepatoblastoma). We restricted our cohort to patients listed for liver transplantation based on MELD-driven indications. This decision was made to reduce heterogeneity and ensure that eligibility determinations were primarily driven by MELD scores, thereby allowing us to isolate the relative contribution of frailty in the context of MELD-based allocation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 1) Peng JK, et al: The impact of cirrhosis on health-related quality of life. Liver International, 2019,39(3), 1234-1242. 2) Alberts CJ, Clifford GM, Georges D, et al (2022): Worldwide prevalence of hepatitis B virus and hepatitis C virus among patients with cirrhosis at country, region, and global levels: a systematic review. Lancet Gastroenterol Hepatol;7(8): 724-735. 3) Bodzin AS, Baker TB: Liver transplantation today: where we are now and where we are going. Liver Transplant: Off Publicat American Assoc Stud Liver Diseas Int Liver Transplant Soc 2018;24:1470-5. 4) Terrault NA, Francoz C, Berenguer M, Charlton M, Heimbach J: Liver transplantation 2023: status report, current and future challenges. Clin Gastroenterol Hepatol : Offi Clin Pract J American Gastroenterol Assocn 2023;21: 2150-66. 5) Hughes CB, Humar A: Liver transplantation: current and future. Abdominal Radiol 2021;46:2-8. 6) Sousa Da Silva RX, Weber A, Dutkowski P, Clavien PA: Machine perfusion in liver transplantation. Hepatology (Baltimore, Md) 2022;76:1531-49. 7) Hoare M, Das T, Alexander G: Ageing, telomeres, senescence, and liver injury. J Hepatol 2010;53:950-61. 8) Saiman Y, Serper M: Frailty and sarcopenia in patients pre- and post-liver transplant. Clin Liver Dis 2021;25:35-51. 9) Zaccherini G, Weiss E, Moreau R: Acute-on-chronic liver failure: definitions, pathophysiology and principles of treatment. JHEP Report :Iinnovat Hepatol 2021; 3:100176. 10) Angeli P, Gines P: Hepatorenal syndrome, MELD score and liver transplantation: an evolving issue with relevant implications for clinical practice. J Hepatol 2012;57: 1135-40. 11) Lai JC, Feng S, Terrault NA, Lizaola B, Hayssen H, Covinsky K: Frailty predicts waitlist mortality in liver transplant candidates. Am J Transplant 2014;14:1870-9. 12) Sinclair M, Poltavskiy E, Dodge JL, Lai JC: Frailty is independently associated with increased hospitalisation days in patients on the liver transplant waitlist. World J Gastroenterol 2017;23:899

    BACKGROUND

MeSH Terms

Conditions

Liver CirrhosisFibrosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 20, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

August 20, 2026

Record last verified: 2026-08