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NCT01575847 · ClinicalTrials.gov registry record
Adduct Dipstick for Diagnosis of Acetaminophen Toxicity
A clinical trial, sponsored by Arkansas Children's Hospital Research Institute.
- Completed
- Registry status
- 120
- Enrollment target
NCT01575847: Completed study, sponsored by Arkansas Children's Hospital Research Institute.
NCT01575847 is a clinical trial that has completed, run by Arkansas Children's Hospital Research Institute. The registered enrollment target is 120 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01575847 has completed, sponsored by Arkansas Children's Hospital Research Institute.
- COMPLETED
- Registry status
- 120 participants
- Enrollment target
Study Summary
This study is a non-intervention, clinical study to test "research use only" APAP protein adducts dipsticks in human blood samples. The study will be conducted in two phases. In phase 1, the research use only dipsticks and dipstick testing components will be tested for feasibility in the emergency department at UAMS. Patients will be enrolled that are having an acetaminophen level obtained as part of their medical evaluation. In phase 2, the research use only dipsticks will be tested in centers that participate in the Acute Liver Failure Study Group (ALFSG), a clinical research network funded by the National Institutes of Diabetes, Digestive and Kidney Diseases (NIDDK). Subjects participating in the clinical registry of the ALFSG will be approached for enrollment. These patients all have the diagnosis of acute liver failure or acute liver injury from a variety of etiologies, including APAP. A single blood sample will be obtained and will be aliquoted for 1) testing by the dipstick and 2) testing by high performance liquid chromatography with electrochemical detection (HPLC-EC) analysis for APAP protein adducts. APAP levels will also be determined from the second aliquot of blood. In both Phase 1 and Phase 2, the dipsticks will be read manually and by dipstick readers by independent testers that are not directly involved in the clinical care of the patients. The results of the two dipstick readings will be recorded, will remain confidential and will not be used in the diagnosis or management of the patient. The results of the dipsticks and HPLC-EC assays will be compared to the final patient diagnoses.
Primary Outcome
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2011-08 |
| Est. Completion | 2016-09 |
What the finished NCT01575847 record still lists
NCT01575847 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01575847 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01575847 about?
NCT01575847 is a clinical study titled "Adduct Dipstick for Diagnosis of Acetaminophen Toxicity". This study is a non-intervention, clinical study to test "research use only" APAP protein adducts dipsticks in human blood samples. The study will be conducted in two phases. In phase 1, the research use only dipsticks and dipstick testing components will be tested for feasibility in the emergency d...
What is the current status of trial NCT01575847?
This trial is currently completed. The enrollment target is 120 participants. The study started on 2011-08. Estimated completion is 2016-09.
Who is sponsoring clinical trial NCT01575847?
This trial is sponsored by Arkansas Children's Hospital Research Institute, which has 97 total clinical trials registered on ClinicalTrials.gov.
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