Skip to main content
OpenTrials
Completed

NCT Number: NCT06025708

Quantra QStat Sample Type Comparison

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coagulation Defect; Bleeding Cardiovascular Diseases Embolism and Thrombosis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

About this study

In this single center prospective observational study, 25 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 75 matched samples for analysis on the Quantra System with the QStat Cartridge.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is >=18 years
  • Subject is scheduled for liver transplant surgery
  • Subject or subject's legally authorized representative (LAR) is willing to provide informed consent

Exclusion criteria

  • Subject is younger than 18 years of age
  • Subject is pregnant
  • Subject is incarcerated at the time of the study
  • Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks
  • Subject, or subject's LAR, is unable or unwilling to provide informed consent

Treatment and study plan

Diagnostic Test: Quantra QStat Cartridge

Device

Whole blood coagulation testing system

Primary outcomes

  1. Comparison of QStat Clot time (CT) in arterial and venous samples

    Time frame: During liver transplantation surgery

    Coagulation function assessed in two sample types

  2. Comparison of QStat Clot stiffness (CS) in arterial and venous samples

    Time frame: During liver transplantation surgery

    Coagulation function assessed in two sample types

  3. Comparison of QStat Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples

    Time frame: During liver transplantation surgery

    Coagulation function assessed in two sample types

  4. Comparison of QStat Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples

    Time frame: During liver transplantation surgery

    Coagulation function assessed in two sample types

  5. Comparison of QStat Clot Stabilty to Lysis (CSL) in arterial and venous samples

    Time frame: During liver transplantation surgery

    Coagulation function assessed in two sample types

Sponsors and collaborators

Lead sponsor

HemoSonics LLC

Industry

Registry information

Official study title

Impact of Sample Type on the Performance of the Quantra QStat System

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 6, 2023
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.