Clinical trial NCT05118048: StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood
Official title: CLIA Waived Study: StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sepsis
Anemia
Bleeding
Erythrocytosis
Keywords: Lactate
Hemoglobin
Hematocrict
Lead sponsor: Nova Biomedical
Sponsor class: INDUSTRY
Collaborators: name: Buffalo General Medical Center
name: Erie County Medical Center
name: Millard Fillmore Suburban Hospital
First posted: 2021-11-11
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pediatric

Primary outcomes:
measure: Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Lactate comparison
timeFrame: 20 days
measure: Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Hemoglobin comparison
timeFrame: 20 days
measure: Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Hematocrit comparison
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Buffalo General Medical Center
state: New York
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: Williamsville
country: United States
facility: Millard Fillmore Suburban Hospital
state: New York
Study officials:
affiliation: Buffalo General Medical Center
name: Brooke Lerner, PhD, FAEMS
role: PRINCIPAL_INVESTIGATOR
affiliation: Erie County Medical Center
name: Brooke Lerner, PhD, FAEMS
role: PRINCIPAL_INVESTIGATOR
affiliation: Millard Fillmore Suburban Hospital
name: Brooke Lerner, PhD, FAEMS
role: PRINCIPAL_INVESTIGATOR
References: