New blood sampling method for monitoring immunosuppressive drugs in children
Microsampling Assays for Immunosuppressive Drugs in Children
This study is testing a new small blood sampling device to see if it can safely and comfortably monitor immunosuppressive drug levels in children who have had organ or stem cell transplants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04989686 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate a novel small volume blood sampling device, Tasso-M20, for monitoring immunosuppressive drug concentrations in children undergoing treatment for solid organ and bone marrow/stem cell transplants. The study will compare the effectiveness and comfort of this new microsampling approach against traditional venous blood collection methods. Additionally, it will assess patient and family perceptions regarding the use of the Tasso-M20 device outside of clinical settings. The goal is to ensure safe and effective dosing of immunosuppressive medications while minimizing the discomfort and risks associated with frequent blood draws.
Who should consider this trial
Good fit: Ideal candidates include children under 18 years old who are receiving cyclosporine A, tacrolimus, or sirolimus as part of their standard care.
Not a fit: Patients who are unable to provide blood samples or do not have a scheduled blood draw for drug concentration monitoring will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a less painful and more convenient method for monitoring immunosuppressive drug levels in children, improving their overall treatment experience.
How similar studies have performed: While the approach of using microsampling for drug monitoring is innovative, similar studies have shown promise in improving patient comfort and compliance in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males and females \<18 years of age 2. Weight greater than 5 kg 3. Receiving CYA, TAC, and/or SIR as standard of care 4. Has scheduled/anticipated blood draw to quantify the concentration of CYA, TAC, and SIR\* for clinical indications 5. Parental/guardian permission (informed consent), and subject's assent if applicable. Exclusion Criteria: 1) Unable to provide blood samples. \* Potential subjects and their parents/guardians may be approached prior to having a blood draw scheduled if they meet all other eligibility criteria. Sub-Study Criteria: Sub-study criteria for child participants will not differ from the main study. Adult participants are required to be a parent/legal guardian of a study subject.
Where this trial is running
Philadelphia, Pennsylvania
- Children's Hospital of Phildelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Kevin J Downes, MD
- Email: downeskj@chop.edu
- Phone: 215-590-4024
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.