Activated Clotting Time
Conditions
Brief summary
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).
Interventions
DIAGNOSTIC_TESTBlood draw
A total volume of no more than 5mL of blood will be prospectively collected from subjects.
Sponsors
Abbott Point of Care
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare ACT test results obtained from two different diagnostic devices. | 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
| Measure | Time frame | Description |
|---|---|---|
| Precision assessment. | 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. |
Countries
United States
Contacts
STUDY_DIRECTORManish Gupta, MS, MBA
Abbott Point of Care
Outcome results
None listed