Activated Clotting TimeACTNCT07382076
Clinical Evaluation of the i-STAT ACTpro Cartridge in an Adult Population
An observational study of Activated Clotting Time, run by Abbott Point of Care at 11 sites in United States.
Trial summary
Measuring Activated Clotting Time (ACT) using the i-STAT ACTpro cartridge on the i-STAT 1 analyzer compared to a comparator device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Activated Clotting Time
- What is being tested?
- Blood draw
- How many people
- 500 participants
- Where
- 11 sitesUnited States
- Study dates
- 18 Dec 2023to 19 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing procedures where venous and arterial whole blood specimens are obtained in different care settings.
Who may be able to join
- 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.
Who cannot join
- Prior enrollment in the study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Maryland
Baltimore, Maryland, 21201
Dignity Health Chandler Regional Medical Center
Chandler, Arizona, 85224
Penn State University Hershey Medical Center
Hershey, Pennsylvania, 17033
Kentucky Clinical Trials Laboratory
Louisville, Kentucky, 40202
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Eastside Research Associates - Redmond
Redmond, Washington, 98052
University of California at San Francisco
San Francisco, California, 94132
Washington University
St Louis, Missouri, 63110
George Washington University
Washington D.C., District of Columbia, 20052
About this study
Official 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
Measuring Activated Clotting Time (ACT) using the i-STAT ACTpro cartridge on the i-STAT 1 analyzer compared to a comparator device.
Read the 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).
- Conditions
- Activated Clotting Time
- Being tested
- Blood draw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawDiagnostic test
A total volume of no more than 5mL of blood will be prospectively collected from subjects.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Approximately thirty (30) to sixty (60) minutes depending on the length of the participants procedure and the number of research blood draws.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start18 Dec 2023
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Activated Clotting TimeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Point of Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manish Gupta, MS, MBA, Study director, Abbott Point of Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382076
- Sponsor's protocol ID
- CS-2022-0009
- Acronym
- ACT
- Status last verified
- Oct 2026
- First submitted
- 26 Jan 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07382076
- Acronym / sponsor ID
- ACT / CS-2022-0009
- Conditions
- Activated Clotting Time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Abbott Point of CareIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Measuring Activated Clotting Time (ACT) using the i-STAT ACTpro cartridge on the i-STAT 1 analyzer compared to a comparator device.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Activated Clotting Time (ACT) in venous and arterial whole blood specimens. | – | Diagnostic Test: Blood drawArterial 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing procedures where venous and arterial whole blood specimens are obtained in different care settings.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Prior enrollment in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawA total volume of no more than 5mL of blood will be prospectively collected from subjects. | Diagnostic test | Activated Clotting Time (ACT) in venous and arterial whole blood specimens. |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manish Gupta, MS, MBA study director
Abbott Point of Care
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Activated Clotting Time, run by Abbott Point of Care at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.