Unknown Cancer NIHR-supported project Digestion, Kidneys & Other Organs

A novel COMBinATorial therapy with albumin and enoxaparin inpatients with decompensated cirrhosis at high-risk of poor outcome(COMBAT trial).

In plain English

AI plain-English summary

A 90-patient clinical trial will test whether combining human albumin with the blood thinner enoxaparin can prevent liver disease patients from rapidly deteriorating after a hospital discharge. This matters because patients with decompensated cirrhosis—a late stage of liver scarring where the organ can no longer function properly—face a high risk of death or needing a liver transplant within months of leaving hospital. Current standard medical therapy does little to alter that trajectory. The trial specifically targets patients with a CLIF-C AD score of 50 or higher, a marker of imminent poor outcome, and randomises them to receive either standard care alone or standard care plus the two-drug combination for up to 90 days. If the combinatorial therapy proves safe and effective, it could become a straightforward, low-cost addition to post-discharge care for high-risk cirrhosis patients. That would directly reduce deaths and liver transplant waiting lists, without requiring new infrastructure or specialist equipment—just a change in prescribing practice. The trial also tracks exploratory biological markers, which may reveal why some patients respond and others do not, guiding future treatment refinements.

View original technical description
A randomized clinical trial comprised of 90 subjects will be conducted to determine primarily whether a combinatorial therapy based on the administration of human albumin and enoxaparinis safe and effective in patients with decompensated cirrhosis discharged from the hospital after an index admission for AD according to the EASL-CLIF criteria. Patients with high risk of poor outcome will be selected based on a CLIF-C AD score >= 50 at any time during index hospitalization. The effects of the combinatorial therapy on exploratory parameters will be also evaluated. After screening and randomization (1:1 ratio) to be performed within 48-72 hours before theexpected discharge, treatment groups will proceed as follows: SMT plus combinatorial therapy SMT (control group) Patients will be treated with the combinatorial therapy up to a maximum of 90 days from inclusion and followed until death or liver transplantation up to a maximum of 180 days from inclusion.

Researchers

Raj Mookerjee (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

IG1601: Prevention of Mortality with Long-Term Administration of Human Albumin in Subjects with Decompensated Cirrhosis and Ascites
IG1601: Prevention of Mortality with Long-Term Administration of Human Albumin in Subjects with Decompensated Cirrhosis and Ascites IND 17549 - EudraCT-Number: 2016-001789-28
ALB-TRIAL: A randomized multicentre, double-blinded and placebo-controlled, trial of human albumin in the treatment of decompensated cirrhosis guided by the Microb-Predict biomarker
Decompensated cirrhosis: Identification of new combinatorial therapies based on systems approaches
Apixaban to Prevent dEcompensation of eArly liver CirrHosis (APEACH)

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