StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood

November 1, 2021 updated by: Nova Biomedical

CLIA Waived Study: StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood

The purpose of this study is to evaluate the clinical utility of the StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System in the testing of whole blood specimens from patients in hospital settings by CLIA waived operators, over a period of at least twenty days. The specimens shall include capillary (obtained by fingerstick), and venous whole blood. The study will also evaluate the use of a Fingerstick Blood Contamination Barrier for capillary sampling from the fingertip. This submission to the FDA is intended for a Point of Care (POC), CLIA waived device for whole blood capillary and venous lactate, and hemoglobin and hematocrit measurements.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted at three (3) different healthcare settings (hereafter referred to as "testing sites") in POC sites/departments, by at least nine (9) CLIAW operators (at least 3 in each healthcare setting), over a period of at least twenty days at each healthcare setting. Examples of hospital departments include (but are not limited to) Emergency Department (ED), Intensive Care Unit (ICU), Pediatric Intensive Care Unit (PICU), Surgical Intensive Care Unit (SICU), Medical Intensive Care Unit (MICU), Cardiac Intensive Care Unit (CICU), Operating Room (OR), where point-of-care lactate, hemoglobin and hematocrit testing can be utilized.

Each site will recruit at least 120 patients for a total of 360 adult patients in all three (3) sites for each of the tests and specimen types. An attempt will be made to enroll 50% males and 50% females.

Each Study Subject will provide:

  1. Two (2) capillary whole blood fingerstick specimens

    1. One Lactate capillary test using the Fingerstick Blood Contamination Barrier
    2. One Hb/Hct capillary test following traditional fingerstick protocol

  2. One (1) venous whole blood specimen obtained by venipuncture collected in a lithium heparin tube or heparinized syringe:

    1. One lactate venous test
    2. One Hb/Hct venous test

Study Type

Observational

Enrollment (Actual)

285

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14203
        • Buffalo General Medical Center
      • Buffalo, New York, United States, 14203
        • Erie County Medical Center
      • Williamsville, New York, United States, 14221
        • Millard Fillmore Suburban Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Each site will recruit at least 120 patients for a total of 360 adult patients in all three (3) sites for each of the tests and specimen types. An attempt will be made to enroll 50% males and 50% females.

Each Study Subject will provide:

  1. Two (2) capillary whole blood fingerstick specimens

    1. One Lactate capillary test using the Fingerstick Blood Contamination Barrier
    2. One Hb/Hct capillary test following traditional fingerstick protocol

  2. One (1) venous whole blood specimen obtained by venipuncture collected in a lithium heparin tube or heparinized syringe:

    1. One lactate venous test
    2. One Hb/Hct venous test

Description

Inclusion Criteria:

  • Adult subjects (over or equal to 18 years old) with ordered hemoglobin and hematocrit

Exclusion Criteria:

  • Pediatric

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Lactate comparison
Time Frame: 20 days
StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System, a point of care testing instrument is as effective as a reference laboratory method for Lactate blood results in mmol/L
20 days
Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Hemoglobin comparison
Time Frame: 20 days
StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System, a point of care testing instrument is as effective as a reference laboratory method for Hemoglobin blood results in g/dL
20 days
Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Hematocrit comparison
Time Frame: 20 days
StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System, a point of care testing instrument is as effective as a reference laboratory method for Hematocrit blood results in %
20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Biomedical

Collaborators

Erie County Medical Center
Buffalo General Medical Center
Millard Fillmore Suburban Hospital

Investigators

  • Principal Investigator: Brooke Lerner, PhD, FAEMS, Buffalo General Medical Center
  • Principal Investigator: Brooke Lerner, PhD, FAEMS, Erie County Medical Center
  • Principal Investigator: Brooke Lerner, PhD, FAEMS, Millard Fillmore Suburban Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2021

Primary Completion (Actual)

October 22, 2021

Study Completion (Actual)

October 22, 2021

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

November 1, 2021

First Posted (Actual)

November 11, 2021

Study Record Updates

Last Update Posted (Actual)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 1, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NB19-SSLHH-NA-FDA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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