NCT04105699

Evaluation of Immunoassay Measurements of Pancreatic Stone Protein Performed on abioSCOPE® Device With the PSP Assay on ICU Patients at Risk of Sepsis as an Aid in Identifying Sepsis

A Multicenter, Prospective, Biomarker-result-blinded Observational Study Evaluating Immunoassay Measurements of Pancreatic Stone Protein Performed on Abionic's abioSCOPE® Device With the PSP Assay on ICU Patients at Risk of Sepsis as an Aid in Identifying Sepsis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 544 (actual)
• Sponsor: Abionic SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on ICU patients at risk of sepsis as an aid in identifying sepsis.

Conditions

• Sepsis

Interventions

Type	Name	Description
DEVICE	Blood sampling	Daily blood sample which will be taken for the PSP measurement using the abioSCOPE as well as another daily sample taken for central analysis of biomarkers of inflammation, infection and/or sepsis (including but not limited to C-reactive protein \[CRP\] and Procalcitonin \[PCT\]).

Timeline

• Start date: 2019-12-10
• Primary completion: 2023-08-23
• Completion: 2023-12-28
• First posted: 2019-09-26
• Last updated: 2024-01-30

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study