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Assessment of Platelet Function in Patients Undergoing Open Heart Surgery

NCT05441358 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2022-07-01

No results posted yet for this study

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

Interventions

PROCEDURE

Open Heart Surgery

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.

Sponsors & Collaborators

  • Sinai Center for Thrombosis Research and Drug Development

    collaborator UNKNOWN

  • Accriva Diagnostics

    collaborator INDUSTRY

  • LifeBridge Health

    lead OTHER

Principal Investigators

  • Paul Gurbel, MD · Sinai Center for Thrombosis Research and Drug Development

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-23
Primary Completion
2022-12-01
Completion
2023-01-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05441358 on ClinicalTrials.gov