Assessment of Platelet Function in Patients Undergoing Open Heart Surgery

NCT05441358 | Unknown

• 1 other identifier: 1813901
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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 cartridge currently under development. A single test cartridge with multiple assays will be compared with Light Transmittance Aggregometry (LTA) within a clinical setting using blood samples. Analytical performance will be compared between these assays. The outcome of this evaluation will be used to demonstrate baseline performance and support the design and development of the Saturn analyzer and optimization of the associated algorithm.

Conditions

Coronary Artery Bypass Grafting; Open Heart Surgery; Aortic Surgery or Redo Surgery; On-pump Double or Triple Valve Procedures

Outcome Measures

Primary Outcomes (1)

• System functionality and analytical performance of Saturn Investigational Instrument and Cartridge

  Comparison of platelet aggregation between Saturn Investigational Instrument and Light Transmittance Aggregation

  48 hours after open heart surgery

Study Arms (1)

Patients undergoing open heart surgery

Subjects 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

Procedure: Open Heart Surgery

Interventions

Open Heart Surgery PROCEDURE

Blood collection at 4 timepoints (prior to anesthesia induction, immediately post-protamine, 1-2 hours post protamine, and up to 48 hours post-surgical completion) to assess platelet function.

Also known as: CABG, Open Heart Valve Replacement

Patients undergoing open heart surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sinai Hospital of Baltimore

You may qualify if:

• 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

You may not qualify if:

• Subject requiring an emergency procedure
• Pregnancy
• Subject is hemodynamically unstable
• Conversion to on-pump
• History of bleeding tendencies
• History of coagulation disorders

Sponsors & Collaborators

• LifeBridge Health: lead
• Sinai Center for Thrombosis Research and Drug Development: collaborator
• Accriva Diagnostics: collaborator

Study Sites (1)

Sinai Center for Thrombosis Research

Baltimore, Maryland, 21215, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

Study Officials

• Paul Gurbel, MD

  Sinai Center for Thrombosis Research and Drug Development

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Bliden, MBA

CONTACT

410-601-4194; kbliden@lifebridgehealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: March 23, 2022
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)