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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Activated Clotting Time
• Intervention / Treatment: Diagnostic test: Blood draw

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Dignity Health Chandler Regional Medical Center
  • California
    • San Francisco, California, United States, 94132
      • University of California at San Francisco
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20052
      • George Washington University
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Kentucky Clinical Trials Laboratory
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • New York, New York, United States, 10029
      • ICAHN School of Medicine at Mount Sinai
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State University Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Washington
    • Redmond, Washington, United States, 98052
      • Eastside Research Associates - Redmond

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing procedures where venous and arterial whole blood specimens are obtained in different care settings.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Blood draw; A total volume of no more than 5mL of blood will be prospectively collected from subjects.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Precision assessment.	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.	Approximately thirty (30) to sixty (60) minutes depending on the length of the participants procedure and the number of research blood draws.

Collaborators and Investigators

• Sponsor: Abbott Point of Care
• Investigators: Study Director: Manish Gupta, MS, MBA, Abbott Point of Care

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: CS-2022-0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes