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

N/AActive Not RecruitingNCT07382076

Abbott Point of Care500 enrolled

Overview

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

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

500

Conditions

Activated Clotting Time

Interventions

Blood drawDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Dignity Health Chandler Regional Medical Center

Chandler, Arizona, United States

University of California at San Francisco

San Francisco, California, United States

George Washington University

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.