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StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood

NCT ID: NCT05118048

Last Updated: 2021-11-11

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

TERMINATED

Total Enrollment

285 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-18

Study Completion Date

2021-10-22

Brief Summary

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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.

Detailed Description

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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

Conditions

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Sepsis Anemia Bleeding Erythrocytosis

Keywords

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Lactate Hemoglobin Hematocrict

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Lactate, Hemoglobin, Hematocrit

Compare diagnostic tests to reference methods

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pediatric
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Buffalo General Medical Center

UNKNOWN

Sponsor Role collaborator

Erie County Medical Center

OTHER

Sponsor Role collaborator

Millard Fillmore Suburban Hospital

UNKNOWN

Sponsor Role collaborator

Nova Biomedical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brooke Lerner, PhD, FAEMS

Role: PRINCIPAL_INVESTIGATOR

Buffalo General Medical Center

Brooke Lerner, PhD, FAEMS

Role: PRINCIPAL_INVESTIGATOR

Erie County Medical Center

Brooke Lerner, PhD, FAEMS

Role: PRINCIPAL_INVESTIGATOR

Millard Fillmore Suburban Hospital

Locations

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Buffalo General Medical Center

Buffalo, New York, United States

Site Status

Erie County Medical Center

Buffalo, New York, United States

Site Status

Millard Fillmore Suburban Hospital

Williamsville, New York, United States

Site Status

Countries

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United States

Other Identifiers

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NB19-SSLHH-NA-FDA

Identifier Type: -

Identifier Source: org_study_id