Clinical Trials

Patient Enrollment

From the beginning, the goal of the ALFSG has been to collect detailed prospective data on patients having this rare condition. Our bio-samples repository contains more than 75,000 specimens.

Acute Liver Failure

The essential features for patient recruitment are:

  • Short-term hepatic illness
  • Coagulopathy (abnormal blood clotting) characterized by a prothrombin time/INR of ≥1.5
  • Any degree of hepatic encephalopathy (mental changes associated with liver failure).

The investigators record the clinical history and physical findings, hospital course, and short- and long-term outcomes. They also collect serum samples, plasma, urine, and DNA, and liver tissue where available.

Acute Liver Injury

Since 2007, a new group of patients has also been enrolled in a separate category of acute liver injury (ALI):

  • Severe hepatocyte injury (INR  2.0 and AST 10x ULN)
  • No evidence of encephalopathy

As of March 1, 2014, enrollment in the ALF study stood at 2,123 and in the ALI study at 423.

Because patients by definition have mental slowing or coma, researchers obtain informed consent from next of kin in all cases. All information obtained is held in strict confidence. No names are used at any time in this study, so the information is truly confidential.

Physicians who wish to refer patients or who have questions regarding this condition may contact one of the nationwide site investigators