Tacrolimus Microsampling

Validate Volumetric Absorptive Microsampling (VAMS) Assay Clinical Trial

— VAMS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04810143
• Other study ID #: 2019-0943
• Status: Completed
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: July 28, 2022

Study information

• Verified date: December 2022
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a feasibility study at a single site, Cincinnati Children's 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 28, 2022
• Est. primary completion date: January 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 21 Years

Eligibility

Inclusion Criteria:

1. Pediatric, adolescent, or young adult patients =1 and =21 years of age

1. Aim 1: All patients presenting for routine post-transplant care including, but not limited to: cardiac catheterization, cardiac biopsy, inpatient admission, or outpatient visits

2. Aim 2: outpatient

2. Currently taking tacrolimus

Exclusion Criteria:

1. Non-English-speaking patients

2. Unable to access overnight delivery services (Aim 2 only)

Related Conditions & MeSH terms

• Validate Volumetric Absorptive Microsampling (VAMS) Assay

Intervention

Device:
• Mitra Microsampler
an FDA Class I medical device for direct specimen collection of blood or other biological fluids

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of +/-10%	A VAMS-based tacrolimus trough values will be accurate +/-10% when compared with standard whole blood values achieved via venipuncture.	18-24 months from start of enrollment