Status:
UNKNOWN
Assessment of Platelet Function in Patients Undergoing Open Heart Surgery
Lead Sponsor:
LifeBridge Health
Collaborating Sponsors:
Sinai Center for Thrombosis Research and Drug Development
Accriva Diagnostics
Conditions:
Coronary Artery Bypass Grafting
Open Heart Surgery
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this external evaluation is to assess the system functionality and analytical performance of the Saturn Investigational Instrument (next generation VerifyNow instrument) and associated ...
Detailed Description
This protocol applies to the evaluation of the Saturn Investigational Instrument and cartridge. LTA will serve as the reference analyzer for this study. The evaluation will be conducted at Sinai Hospi...
Eligibility Criteria
Inclusion
- Subject is at least 18 years of age
- Subject scheduled for elective cardiothoracic surgery requiring a sternotomy
- Coronary artery bypass grafting (CABG)
- Combined CABG and valve surgery
- On-pump double or triple valve procedures
- Aortic surgery or redo surgery
- Off pump CABG as part of a hybrid revascularization approach
- Able to read and has signed and dated the informed consent form
Exclusion
- Subject requiring an emergency procedure
- Pregnancy
- Subject is hemodynamically unstable
- Conversion to on-pump
- History of bleeding tendencies
- History of coagulation disorders
Key Trial Info
Start Date :
March 23 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05441358
Start Date
March 23 2022
End Date
January 1 2023
Last Update
July 1 2022
Active Locations (1)
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1
Sinai Center for Thrombosis Research
Baltimore, Maryland, United States, 21215