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Quantra Determination of Coagulation Parameters in Arterial and Venous Blood

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HemoSonics

Status

Completed

Conditions

Cardiac Surgery

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT02978872
HEMCS-005

Details and patient eligibility

About

The Quantra™ System is a novel point-of-care diagnostic device designed to perform whole blood coagulation analysis. This study compares Quantra measurements determined in arterial versus venous blood samples obtained from patients undergoing cardiac surgery.

Full description

The Quantra System is a fully integrated and automated in vitro diagnostic device which utilizes SEER Sonorheometry, an ultrasound-based technology, to characterize the dynamic changes in the viscoelastic properties of a blood sample during coagulation and clot lysis. Viscoelastic testing performed using existing technologies is typically performed on arterial samples obtained from patients undergoing surgical procedures, although reference ranges for these tests have been established for venous blood only.

The aim of this study is to evaluate potential differences between Quantra measurements determined in arterial versus venous blood samples obtained from patients undergoing cardiac surgery.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject is scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or including placement of a ventricular assist device
  • Subject is ≥18 years
  • Subject is willing to participate and he/she has signed a consent form
  • Subject may participate if they have a history of bleeding or are on preoperative anticoagulant therapy

Exclusion criteria

  • Subject is unable to provide written informed consent
  • Subject is younger than 18 years
  • Subject is incarcerated at the time of the study
  • Subject is currently enrolled in a study that may confound the results of the proposed study
  • Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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