Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®)

Recruiting

• Conditions: Phenylketonuria; Metabolic Diseases

• Registration Number: NCT05894122
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

The aim is to demonstrate a new application for a blood collection device. This device is already widely used in pharmacology. It is not currently used for metabolic diseases.

Its ease of use enables repeated sampling at home. What's more, the device can be sent by post, making it ideally suited to the needs of this cohort of children, whose phenylalanine levels need to be monitored very regularly.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-08
• Status Verified: 2023-12
• Study Start: 2023-12-13
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-22
• Primary Completion: 2025-12-12
• Study Completion: 2025-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Children aged 3 months to 18 years
• suffering from phenylketonuria or hyperphenylalaninemia
• who have had a capillary and blood test including a phenylalanine assay at CHUGA
• Whose parents or legal guardians are affiliated to the social security system.
• For whom parents or legal guardians have not objected to the MitrAlanine study.

Exclusion Criteria

• Parents or legal guardians opposed to the MitrAlanine study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of phenylalanine concentrations	Day 1	Comparison of phenylalanine concentrations in the new device with those in the current device (blotter).

Secondary Outcome Measures

Name	Time	Method
Ease of use of research device	Day 1	ease of use of DM-DIV MITRA® and DM-DIV HemaPEN® via a 3 questions-and-answer guide for samplers
sample conformity	Day 1	Conformity of blood sample on DM-DIV MITRA® and DM-DIV HemaPEN® versus DM-DIV Perkin Elmer
comparison of concentrations of tyrosin	Day 1	comparison of concentrations of other amino acids (tyrosin) dosed at the same time as phenylalanine
comparison of concentrations of total leucin	Day 1	comparison of concentrations of other amino acids (total leucin) dosed at the same time as phenylalanine
comparison of concentrations of methionin	Day 1	comparison of concentrations of other amino acids (methionin) dosed at the same time as phenylalanine

Trial Locations

Locations (1)

CHU Grenoble Alpes; 🇫🇷 Grenoble, France