Clinical Evaluation of the i-STAT ACTpro Cartridge in an Adult Population
ACT
1 other identifier
observational
500
1 country
11
Brief Summary
Measuring Activated Clotting Time (ACT) using the i-STAT ACTpro cartridge on the i-STAT 1 analyzer compared to a comparator device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2023
Typical duration for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2023
CompletedFirst Submitted
Initial submission to the registry
January 26, 2026
CompletedFirst Posted
Study publicly available on registry
February 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2026
CompletedFebruary 2, 2026
January 1, 2026
2.3 years
January 26, 2026
January 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Precision assessment.
Approximately thirty (30) to sixty (60) minutes depending on the length of the participants procedure and the number of research blood draws.
Study Arms (1)
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.
Interventions
A total volume of no more than 5mL of blood will be prospectively collected from subjects.
Eligibility Criteria
Adults undergoing procedures where venous and arterial whole blood specimens are obtained in different care settings.
You may qualify if:
- Subject is prescribed unfractionated heparin (UFH) peri-procedurally in order to reduce the risk of blood clots.
- \- 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.
You may not qualify if:
- Prior enrollment in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Dignity Health Chandler Regional Medical Center
Chandler, Arizona, 85224, United States
University of California at San Francisco
San Francisco, California, 94132, United States
George Washington University
Washington D.C., District of Columbia, 20052, United States
Kentucky Clinical Trials Laboratory
Louisville, Kentucky, 40202, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
Washington University
St Louis, Missouri, 63110, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Penn State University Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Eastside Research Associates - Redmond
Redmond, Washington, 98052, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Manish Gupta, MS, MBA
Abbott Point of Care
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2026
First Posted
February 2, 2026
Study Start
December 15, 2023
Primary Completion
March 30, 2026
Study Completion
March 30, 2026
Last Updated
February 2, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share