Status:

COMPLETED

Quantra QPlus Sample Type Comparison

Lead Sponsor:

HemoSonics LLC

Conditions:

Coagulation Defect; Bleeding

Eligibility:

All Genders

18+ years

Brief Summary

This is a single center prospective observational study to compare QPlus parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing cardiac surgery.

Detailed Description

In this single center prospective observational study, 40 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 120 matched samples ...

Eligibility Criteria

Inclusion

  • Subject is scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or including placement of a ventricular assist device
  • Subject is ≥18 years
  • Subject or subject's legally authorized representative is willing to participate and he/she has signed a consent formr.

Exclusion

  • Subject is younger than 18 years
  • Subject is pregnant
  • Subject is incarcerated at the time of the study
  • Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks
  • Subject, or subject's legally aurthorized representative is able to provide written informed consent

Key Trial Info

Start Date :

November 4 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 2 2022

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT05290675

Start Date

November 4 2021

End Date

November 2 2022

Last Update

May 1 2023

Active Locations (1)

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1

Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210