Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810143
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2021-03-17
Brief Title:
Tacrolimus Microsampling
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Development of an Assay for Tacrolimus Blood Trough Measurement in Pediatric Heart Transplant Patients Using Volumetric Absorptive Microsampling VAMS and Stable-Labeled Isotope Dilution Tandem Mass Spectrometry
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VAMS
Brief Summary:
This is a feasibility study at a single site Cincinnati Childrens Hospital Medical Center Patients who have undergone heart transplantation who meet eligibility requirements will be approached to participate in the study The purpose of this study is to establish a reliable home-based method for collecting samples as well as a standardized method for use of small-volume samples on both inpatients and outpatients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None