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NCT Number: NCT07382076

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Activated Clotting Time

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dignity Health Chandler Regional Medical Center, Chandler, Arizona, United States

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About this study

The purpose of this study is to conduct a clinical evaluation of the investigational i-STAT ACTpro cartridge on the i-STAT 1 analyzer compared to a comparator device for measuring Activated Clotting Time (ACT) on venous and arterial whole blood specimens from adult participants.

The study will be conducted using whole blood specimens from participants undergoing Dialysis, Extracorporeal Life Support (ECLS)/ Extracorporeal Membrane Oxygenation (ECMO), and procedures in Electrophysiology Laboratories (EP Labs), Cardiac Catheterization Laboratories (Cath Labs), Interventional Radiology (IR) Units, and Cardiovascular Operating Rooms (CVOR).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is prescribed unfractionated heparin (UFH) peri-procedurally in order to reduce the risk of blood clots.

OR

  • Subject for which only the baseline specimen (prior to UFH administration) is collected, subject is admitted for a medical procedure that would or could typically necessitate the use of UFH to reduce the risk of blood clots.

Exclusion criteria

  • Prior enrollment in the study.

Treatment and study plan

Blood draw

Diagnostic Test

A total volume of no more than 5mL of blood will be prospectively collected from subjects.

Primary outcomes

  1. 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.

    Compare ACT test results obtained from the ACTpro cartridge using the i-STAT 1 analyzer with the ACT test result obtained from a comparator device using whole blood specimens.

Secondary outcomes

  1. Precision assessment.

    Time frame: Approximately thirty (30) to sixty (60) minutes depending on the length of the participants procedure and the number of research blood draws.

    Conduct an assessment of precision for the ACT test using duplicate results generated using the i-STAT ACTpro cartridge on the i-STAT 1 analyzer.

Sponsors and collaborators

Lead sponsor

Abbott Point of Care

Industry

Registry information

Official study title

Clinical Evaluation of the i-STAT ACTpro Cartridge Using Venous and Arterial Whole Blood Specimens on the i-STAT 1 Analyzer in an Adult Population

Acronym: ACT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.