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OpenTrials
Completed

NCT Number: NCT04810143

Tacrolimus Microsampling

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.

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Key information

Conditions

Validate Volumetric Absorptive Microsampling (VAMS) Assay

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric, adolescent, or young adult patients ≥1 and ≤21 years of age
  • Aim 1: All patients presenting for routine post-transplant care including, but not limited to: cardiac catheterization, cardiac biopsy, inpatient admission, or outpatient visits
  • Aim 2: outpatient
  • Currently taking tacrolimus

Exclusion criteria

  • Non-English-speaking patients
  • Unable to access overnight delivery services (Aim 2 only)

Treatment and study plan

Mitra Microsampler

Device

an FDA Class I medical device for direct specimen collection of blood or other biological fluids

Primary outcomes

  1. Accuracy of +/-10%

    Time frame: 18-24 months from start of enrollment

    A VAMS-based tacrolimus trough values will be accurate +/-10% when compared with standard whole blood values achieved via venipuncture.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study 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.

Acronym: VAMS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2021
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.