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Immunosuppressant

Mitra Microsampler for Volumetric Absorptive Microsampling Assay (VAMS Trial)

N/A
Waitlist Available
Led By Thomas C Ryan
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18-24 months from start of enrollment
Awards & highlights

VAMS Trial Summary

This trial is testing a new way to collect and use small samples of blood from heart transplant patients at Cincinnati Children's Hospital.

VAMS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

VAMS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18-24 months from start of enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18-24 months from start of enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accuracy of +/-10%

VAMS Trial Design

2Treatment groups
Experimental Treatment
Group I: Aim 2Experimental Treatment1 Intervention
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.
Group II: Aim 1Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mitra Microsampler
2019
N/A
~20

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
814 Previous Clinical Trials
6,531,565 Total Patients Enrolled
Thomas C RyanPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
1 Previous Clinical Trials
30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025