Adduct Dipstick for Diagnosis of Acetaminophen Toxicity
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|ClinicalTrials.gov Identifier: NCT01575847|
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : January 4, 2017
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Adduct Dipstick for Diagnosis of Acetaminophen Toxicity|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||September 2016|
Part 1 will be a feasibility study conducted in the Emergency Department at UAMS and ACH. This Part will test the research use dipsticks and dipstick testing kit in subjects that are having APAP levels obtained as part of their medical evaluation.
Part 1 20 subjects
Subject is 12-18 years of age. Subject has an APAP level ordered as part of clinical management.
Previous recent history of APAP overdose in the previous 30 days.
Part 2 will be a non-intervention study in adults presenting to hepatology centers participating in the Acute Liver Failure Study Group (ALFSG). The dipstick will be tested in these subjects and the results will be compared to the HPLC-EC measurement of APAP protein adducts. The results of the dipstick testing will not be used for diagnosis or clinical decision-making.
Part 2 100 subjects
Subject is 18 years of age or older. Subject is enrolled in the ALFSG registry.
- Accuracy of dipstick compared to HPLC-EC Method for detecting assays [ Time Frame: Each subject will have one sample taken but chart review could last entire hospitalization expected average of 2 weeks ]The primary purpose of this study is to pilot test the study procedures including the dipstick, dipstick instructions, micro-centrifuges, and dipstick readers in a clinical setting and then in the second phase the primary objective will be to compare the results from the dipstick to the currently used method HPLC-EC
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575847
|United States, Arkansas|
|University of Arkansas for Medical Sciences/Arkansas Children's Hospital|
|Little Rock, Arkansas, United States, 72202|
|Principal Investigator:||Henry Farrar, MD||University of Arkansas|