StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood

NCT05118048 | Terminated FDA Device

• 1 other identifier: NB19-SSLHH-NA-FDA
• Study Type: observational
• Target: 285
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Sepsis; Anemia; Bleeding; Erythrocytosis

Keywords

Lactate; Hemoglobin; Hematocrict

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

Lactate, Hemoglobin, Hematocrit DIAGNOSTIC_TEST

Compare diagnostic tests to reference methods

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Pediatric

Sponsors & Collaborators

• Nova Biomedical: lead
• Buffalo General Medical Center: collaborator
• Erie County Medical Center: collaborator
• Millard Fillmore Suburban Hospital: collaborator

Study Sites (3)

Buffalo General Medical Center

Buffalo, New York, 14203, United States

Location

Erie County Medical Center

Buffalo, New York, 14203, United States

Location

Millard Fillmore Suburban Hospital

Williamsville, New York, 14221, United States

Location

MeSH Terms

Conditions

Sepsis; Anemia; Hemorrhage; Polycythemia

Interventions

Hematocrit

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Hemorheology; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: November 11, 2021
• Study Start: January 18, 2021
• Primary Completion: October 22, 2021
• Study Completion: October 22, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)