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Serum Acetaminophen-Cystein (APAP-CYS) Adduct Concentrations in Subjects Expected to Develop Aminotransferase Elevations with Liver-Directed Therapy Intended to Treat Hepatic Tumors
Primary Objective
To describe serum acetaminophen-cysteine adduct (an experimental biomarker of acetaminophen exposure) concentrations following hepatic embolization in patients taking therapeutic doses of acetaminophen three days before the procedure
Description
This study aims to describe protein adduct (an experimental biomarker of acetaminophen exposure) concentrations in patients taking therapeutic doses of acetaminophen who develop a liver injury from a cause other than acetaminophen.
Details
Age
Adult
Eligibility
Adult patients undergoing portal vein or bland embolization for the treatment of metastatic liver tumor; no known hypersensitivity or allergy to acetaminophen
Detailed Eligibility: Patients are not eligible with: known cirrhosis; history of moderate to severe anemia; currently taking warfarin, isoniazid, and disulfiram; weigh less than or equal to 50kg, pregnant or breastfeeding, and currently enrolled in a clinical trial
Phase
IV - Research Studies occurring after FDA has approved a drug for marketing. These studies gather additional information about a drug's safety, efficacy, or optimal use.
Type of Study
Basic Science
Scope
Local
Locations
Denver Health Medical Center
University of Colorado Hospital
Principal Investigator
Kennon Heard, MD
Study ID
Protocol Number: 16-0031
ClinicalTrials.gov: NCT02911961
Categories
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