CompletedNot Applicable

Tacrolimus Microsampling

United States16 participantsStarted 2019-10-07

Plain-language 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.

Who can participate

Age range1 Year – 21 Years

SexALL

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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)

What they're measuring

Accuracy of +/-10%

Timeframe: 18-24 months from start of enrollment

Trial details

NCT IDNCT04810143

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-03

View on ClinicalTrials.gov More Validate Volumetric Absorptive Microsampling (VAMS) Assay trials