Decompensated cirrhosis is associated with severe complications and frequent hospitalizations, significantly affecting patients’ quality of life. The COMBAT trial, conducted as part of the DECISION project, aims to evaluate if a combinationatorial therapy of albumin and low-dose enoxaparin can prevent complications and reduce hospital stays. If successful, this study could lead to an improved standard of care for patients with decompensated cirrhosis at high risk of poor outcome.

The first patient was enrolled at Hôpital Beaujon, France, one of the participating sites in this international effort. The study is being conducted across leading hospitals in France, Germany, Italy, and Spain, ensuring a diverse and representative patient population.

Eligible patients are those with cirrhosis who are about to be discharged following an acute complication. Participants in the COMBAT trial are randomly assigned to one of two groups: one receiving standard medical treatment and the other receiving standard medical treatment plus albumin and enoxaparin. Both albumin and enoxaparin are commonly used in decompensated cirrhosis, but the complementary combination of these two different therapies has not yet been tested.

Patients with advanced decompensated cirrhosis face recurrent complications that often lead to emergency hospitalizations. By potentially reducing these events, the COMBAT trial could not only improve patient outcomes but also alleviate the burden on healthcare systems. Pierre-Emmanuel Rautou, Coordinator of the DECISION project explained: “Mortality after acute decompensation of cirrhosis remains high (around 13% at three months). Novel therapeutic approaches are thus needed.”
If the combination therapy proves safe, it may redefine treatment strategies for this vulnerable population. “If this safety trial is successful, it will pave the way for an efficacy trial”, Rautou added.

The EF CLIF Data Management Center is instrumental in handling clinical data throughout the study, ensuring integrity and overcoming operational challenges. Our team of data managers has provided training to all researchers involved in the COMBAT trial to ensure consistency across participating centers.

With recruitment now underway, researchers anticipate gathering initial data in the following two years. Trial results could provide valuable insights into whether this combinatorial therapy can improve standard treatment for decompensated cirrhosis, potentially setting new clinical guidelines.

For more information on COMBAT trial and recruiting sites, visit ClinicalTrials.gov (NCT05895136).