An interventional study of Mitra Microsampler in Validate Volumetric Absorptive Microsampling (VAMS) Assay, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 1 Year to 21 Years. Per ClinicalTrials.gov, last updated 2022-12-20.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Device feasibility
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.
Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 133 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 31 (55%) have results posted.
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Pediatric, adolescent, or young adult patients ≥1 and ≤21 years of age
Exclusion Criteria:
All patients presenting for routine post-transplant care including, but not limited to: cardiac catheterization, cardiac biopsy, inpatient admission, or outpatient visits. A convenience sample of 25 inpatient samples will be collected for Aim 1. Although the assay developed by the MSCF will be validated for accuracy, the purpose of Aim 1 is to test "real world" application of the Mitra Microsampler tubes against the gold standard of blood collected by venipuncture in a controlled setting. To accomplish this, consecutive inpatient heart transplant patients will be enrolled. That sample will be collected at the same time (+/- 15 minutes) as a clinically-indicated, appropriately-timed venipuncture for measurement of a tacrolimus trough and prior to the subject taking tacrolimus so as to represent a trough.
Device: Mitra Microsampler
Outpatient. A convenience sample of 25 outpatients collecting 1-2 samples will be collected for Aim 2. For those who agree to participate, the parent/patient will be taught by a member of the team on how to use the Microsampler to collect blood from a finger stick. They will be provided with a kit for collection of up to 2 samples and will also be provided with appropriate shipping materials to return samples to CCHMC. Participants will then be instructed to collect a sample in the Mitra Microsampler via fingerstick. In addition to the process of collecting the sample in Aim 2, appropriately-aged participants and/or families will be asked to fill out a brief survey regarding sample collection. This will include questions about the ease or difficulty of performing the steps and tolerability of the procedure relative to past experiences with values obtained by venipuncture.
Device: Mitra Microsampler
an FDA Class I medical device for direct specimen collection of blood or other biological fluids
Accuracy of +/-10%
A VAMS-based tacrolimus trough values will be accurate +/-10% when compared with standard whole blood values achieved via venipuncture.
Time frame: 18-24 months from start of enrollment
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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