StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05118048
• Other study ID #: NB19-SSLHH-NA-FDA
• Status: Terminated
• Start date: January 18, 2021
• Est. completion date: October 22, 2021

Study information

• Verified date: July 2021
• Source: Nova Biomedical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 285
• Est. completion date: October 22, 2021
• Est. primary completion date: October 22, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pediatric

Related Conditions & MeSH terms

• Anemia
• Bleeding
• Erythrocytosis
• Polycythemia
• Sepsis

Intervention

Diagnostic Test:
• Lactate, Hemoglobin, Hematocrit
Compare diagnostic tests to reference methods

Locations

Country	Name	City	State
United States	Buffalo General Medical Center	Buffalo	New York
United States	Erie County Medical Center	Buffalo	New York
United States	Millard Fillmore Suburban Hospital	Williamsville	New York

Sponsors (4)

Lead Sponsor	Collaborator
Nova Biomedical	Buffalo General Medical Center, Erie County Medical Center, Millard Fillmore Suburban Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Lactate comparison	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
Primary	Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Hemoglobin comparison	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
Primary	Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Hematocrit comparison	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