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

First listed

Feb 2, 2026

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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