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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw | Diagnostic Test | A total volume of no more than 5mL of blood will be prospectively collected from subjects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately thirty (30) to sixty (60) minutes depending on the length of the participants procedure and the number of research blood draws. |
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Inclusion Criteria:
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:
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Adults undergoing procedures where venous and arterial whole blood specimens are obtained in different care settings.
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| Name | Affiliation | Role |
|---|---|---|
| Manish Gupta, MS, MBA | Abbott Point of Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dignity Health Chandler Regional Medical Center | Chandler | Arizona | 85224 | United States | ||
| University of California at San Francisco |
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| 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 |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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