Skip to main content
OpenTrials
Completed

NCT Number: NCT04114253

QStat in Liver Transplant

This study will assess the clinical performance of the Quantra System with the QStat Cartridge in the liver transplant population.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Blood Loss, Surgical Cardiovascular Diseases Embolism and Thrombosis Hemorrhage Intraoperative Complications 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

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic propoerties of a whole blood sample during coagulation. The Quantra QStat Cartridge was developed to monitor hemostasis in the trauma and liver transplant populations which may experience a range of coagulopathies of various etiologies including fibrinolytic defects.

This single-center, prospective, observational stuey will evaluate the performance of the Quantra System with the QStat Cartridge as compared to corresponding measures determined using the TEG 5000.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is ≥ 18 years of age
  • Subject is undergoing deceased donor liver transplant and is a candidate for a TEG test to be performed to access coagulopathy during surgery.
  • Subject is willing to participate, and is willing to consent (either prospectively or by deferred consent)

Exclusion criteria

  • Subject is younger than 18 years of age
  • Subject is known to have received antifibrinolytic therapy immediately prior to the start of liver transplantation surgery.
  • Subject is unable to provide written informed consent (either prior to performing any study related procedures or by deferred consent)
  • Subject is currently enrolled in a distinct study that might confound the results of the proposed study
  • Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks

Treatment and study plan

Quantra System

Diagnostic Test

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Other names: Quantra QStat Cartridge

Primary outcomes

  1. Comparison of Quantra Clot Time results to TEG R results

    Time frame: Baseline, after induction of anesthesia, before surgical incision

    Coagulation function assessed by Quantra and TEG 5000

  2. Comparison of Quantra Clot Stiffness results to TEG MA results

    Time frame: Baseline, after induction of anesthesia, before surgical incision

    Coagulation function assessed by Quantra and TEG 5000

  3. Comparison of Quantra Clot Lysis results to TEG LI30 results

    Time frame: Baseline, after induction of anesthesia, before surgical incision

    Coagulation function assessed by Quantra and TEG 5000

  4. Comparison of Quantra Clot Time results to TEG R results

    Time frame: During surgery

    Coagulation function assessed by Quantra and TEG 5000

  5. Comparison of Quantra Clot Stiffness results to TEG MA results

    Time frame: During surgery

    Coagulation function assessed by Quantra and TEG 5000

  6. Comparison of Quantra Clot Lysis results to TEG LI30 results

    Time frame: During surgery

    Coagulation function assessed by Quantra and TEG 5000

Sponsors and collaborators

Lead sponsor

HemoSonics LLC

Industry

Registry information

Official study title

Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Liver Transplant

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 3, 2019
Registry last updated
Jan 5, 2021

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.