StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood

Stopped early

Conditions studied: Sepsis, Anemia, Bleeding, Erythrocytosis

In brief

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.

Key facts

Study ID

NCT05118048

Run by

Nova Biomedical

People needed

285

Starts

2021-01-18

Expected to finish

2021-10-22

Last updated by the study team

2021-11-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Pediatric

Where it is running

• 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, United States

Full record on ClinicalTrials.gov

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