Clinical Evaluation of the i-STAT ACTpro Cartridge in an Adult Population

Conditions

• Activated Clotting Time

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Blood draw — DIAGNOSTIC_TEST
  A total volume of no more than 5mL of blood will be prospectively collected from subjects.

Study Details

Measuring Activated Clotting Time (ACT) using the i-STAT ACTpro cartridge on the i-STAT 1 analyzer compared to a comparator device.

Key Dates

Start date

Dec 15, 2023

Status verified

Jan 2026

Primary completion

Mar 30, 2026

Completion

Mar 30, 2026

Study Design

Enrollment

500 participants (actual)

Arms

• Arm: Activated Clotting Time (ACT) in venous and arterial whole blood specimens.
  Arterial and/or venous specimens from enrolled subjects will be tested in duplicate on the i-STAT 1 analyzer with the i-STAT ACTpro cartridge, and on the comparator device.

Primary Outcome Measure

Compare ACT test results obtained from two different diagnostic devices. [ Time Frame: Approximately thirty (30) to sixty (60) minutes depending on the length of the participants procedure and the number of research blood draws. ]

Locations (11)

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