Trials / Completed
CompletedNCT04810143
Tacrolimus Microsampling
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Academic / Other
- Sex
- All
- Age
- 1 Year – 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Mitra Microsampler | an FDA Class I medical device for direct specimen collection of blood or other biological fluids |
Timeline
- Start date
- 2019-10-07
- Primary completion
- 2022-01-03
- Completion
- 2022-07-28
- First posted
- 2021-03-22
- Last updated
- 2022-12-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04810143. Inclusion in this directory is not an endorsement.