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Completed

NCT Number: NCT04312958

Quantra QStat in Trauma and Liver Transplant

This is a multi-center prospective, observational study of the Quantra System with the QStat Cartridge in trauma patients and patients undergoing liver transplant.

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Key information

Conditions

Hemorrhage Cardiovascular Diseases Embolism and Thrombosis Liver Transplant Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Trauma Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco, California, United States

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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 properties of a whole blood sample during coagulation. The QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies, including fibrinolytic defects. These patients include the trauma and liver transplant populations. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system.

This multi-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to conventional viscoelastic testing methods in blood samples obtained from trauma patients and patients undergoing liver transplant.

Who can participate

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

Inclusion criteria

  • Subject is > 18 years
  • Subject is a trauma patient experiencing traumatic injuries requiring a full trauma team response OR Subject is a patient undergoing liver transplant surgery.
  • Subject, or subject's legally authorized representative (LAR), is willing to provide informed consent, either prospectively or by deferred consent, OR Institutional Review Board (IRB)/Ethics Committee (EC) has waived the requirement to obtain 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 currently enrolled in a distinct study that might confound the result of the proposed study
  • Subject is affected by a condition that, in the opinion of the surgical 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 (CT) to ROTEM Delta INTEM CT results

    Time frame: Upon arrival of trauma subject to the emergency department

    Coagulation function assessed by Quantra and ROTEM Delta

  2. Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results

    Time frame: Baseline, immediately before the start of liver transplant surgery

    Coagulation function assessed by Quantra and ROTEM Delta

  3. Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results

    Time frame: During anhepatic phase of liver transplant surgery

    Coagulation function assessed by Quantra and ROTEM Delta

  4. Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results

    Time frame: During post-reperfusion phase of liver transplant surgery

    Coagulation function assessed by Quantra and ROTEM Delta

  5. Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results

    Time frame: Upon arrival of trauma subject to the emergency department

    Coagulation function assessed by Quantra and ROTEM Delta

  6. Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results

    Time frame: Baseline, immediately before the start of liver transplant surgery

    Coagulation function assessed by Quantra and ROTEM Delta

  7. Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results

    Time frame: During anhepatic phase of liver transplant surgery

    Coagulation function assessed by Quantra and ROTEM Delta

  8. Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results

    Time frame: During post-reperfusion phase of liver transplant surgery

    Coagulation function assessed by Quantra and ROTEM Delta

  9. Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results

    Time frame: Upon arrival of trauma subject to the emergency department

    Coagulation function assessed by Quantra and ROTEM Delta

  10. Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results

    Time frame: Baseline, immediately before the start of liver transplant surgery

    Coagulation function assessed by Quantra and ROTEM Delta

  11. Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results

    Time frame: During anhepatic phase of liver transplant surgery

    Coagulation function assessed by Quantra and ROTEM Delta

  12. Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results

    Time frame: During post-reperfusion phase of liver transplant surgery

    Coagulation function assessed by Quantra and ROTEM Delta

  13. Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results

    Time frame: Upon arrival of trauma subject to the emergency department

    Coagulation function assessed by Quantra and ROTEM Delta

  14. Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results

    Time frame: Baseline, immediately before the start of liver transplant surgery

    Coagulation function assessed by Quantra and ROTEM Delta

  15. Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results

    Time frame: During anhepatic phase of liver transplant surgery

    Coagulation function assessed by Quantra and ROTEM Delta

  16. Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results

    Time frame: During post-reperfusion phase of liver transplant surgery

    Coagulation function assessed by Quantra and ROTEM Delta

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 Trauma and Liver Transplantation

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 18, 2020
Registry last updated
May 3, 2023

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.

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