Clinical Evaluation of i-STAT Analyzer Glucose, Hematocrit and Sodium for Capillary Samples

NCT ID: NCT02897154

Last Updated: 2018-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

297 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-10

Study Completion Date

2017-03-15

Brief Summary

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The objective of this study is to compare the performance of two i-STAT Analyzers in a Point-of-Care (POC) setting. The evaluation will be performed using a cartridge to test glucose, hematocrit and sodium on capillary specimens.

Detailed Description

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The clinical performance for glucose, hematocrit and sodium assays for capillary samples was evaluated for the investigational i-STAT 500 (Alinity) analyzer based on results of method comparison testing against the i-STAT 1W analyzer.

Conditions

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Analytical Performance of Sodium, Glucose and Hematocrit Assays by the i-STAT 500 (Alinity) Analyzer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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In-vitro

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Subject is ≥ 18 years of age
* Subjects (or their legal representative) who are willing to voluntarily consent to the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Point of Care

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris P Edwards, BSc

Role: STUDY_DIRECTOR

Abbott Point of Care

Locations

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Diablo Clinical Research

Walnut Creek, California, United States

Site Status

Kentucky Clinical Trials Laboratory

Louisville, Kentucky, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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CS-2016-0003

Identifier Type: -

Identifier Source: org_study_id

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