This study is in progress, not accepting new patients

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

a study on Activated Clotting Time

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

Summary

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

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

Details

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).

Keywords

Activated Clotting Time, Blood Specimen Collection, Blood draw, Activated Clotting Time (ACT) in venous and arterial whole blood specimens.

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • Prior enrollment in the study.

Locations

  • University of California at San Francisco
    San Francisco California 94132 United States
  • Dignity Health Chandler Regional Medical Center
    Chandler Arizona 85224 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Point of Care
ID
NCT07382076
Study Type
Observational
Participants
About 500 people participating
Last Updated