Recruiting

Platelet Function

Sponsor:

LifeBridge Health

Code:

NCT05441358

Conditions

Coronary Artery Bypass Grafting

Open Heart Surgery

Aortic Surgery or Redo Surgery

On-pump Double or Triple Valve Procedures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Open Heart Surgery

Study Details

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

Study ID

NCT05441358

Start date

Mar 23, 2022

Status verified date

Jun, 2022

Completion date

Jan 1, 2023

Anticipated

Primary completion date

Dec 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

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

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

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.

Primary outcome measure

  • System functionality and analytical performance of Saturn Investigational Instrument and Cartridge [ Time Frame: 48 hours after open heart surgery ]

Central Contacts and Locations

Central contacts

Kevin Bliden, MBA

410-601-4194kbliden@lifebridgehealth.org

Locations

Sinai Center for Thrombosis Research

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Kevin Bliden, MBA

410-601-4194kbliden@lifebridgehealth.org

More Information

Sponsor

LifeBridge Health

Last update posted

Jul 1, 2022

Last verified

Jun, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by LifeBridge Health on 2022-07-01.