Li-Hep vs. Non-Li-Hep Coated Transfer Device

NCT04458155 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2022-06-10

No results posted yet for this study

Summary

This study is a prospective, diagnostic, cohort study within the standard care of acute coronary syndrome (ACS) patients. It compares the analytical performance of Siemens® point-of-care high sensitive troponin I testing in venous, plasma and capillary sample types. The investigators hypothesize that there is a good correlation between the Siemens® POC HS cTnI assay results for the three sample types and that the bias between different POC sample types reduces from \~10% to ≤ 5% when using heparinized transfer device for the capillary sample.

Conditions

Interventions

DEVICE

Siemens® Point-of-care high sensitive troponin I analyzer

Point-of-care (POC) high sensitive troponin I (HS cTnI) analysis in whole blood, plasma and capillary whole blood with the Siemens® device.

Sponsors & Collaborators

  • Siemens Corporation, Corporate Technology

    collaborator INDUSTRY
  • VieCuri Medical Centre

    lead OTHER

Principal Investigators

  • Braim Rahel, Dr. · VieCuri Medical Centre

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-18
Primary Completion
2020-12-19
Completion
2021-04-01

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04458155 on ClinicalTrials.gov