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Quantra QStat in Trauma and Liver Transplant

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ClinicalTrials.gov Identifier: NCT04312958
Recruitment Status : Enrolling by invitation
First Posted : March 18, 2020
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
HemoSonics LLC

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

Condition or disease Intervention/treatment
Hemorrhage Trauma Liver Transplant Diagnostic Test: Quantra System

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma and Liver Transplantation
Actual Study Start Date : July 20, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Trauma patients
Trauma patients experiencing traumatic injuries requiring a full trauma team response.
Diagnostic Test: Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Other Name: Quantra QStat Cartridge

Liver transplant patients
Patients undergoing liver transplant surgery.
Diagnostic Test: Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Other Name: Quantra QStat Cartridge




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Potential study participants will be adult (>18 years) trauma patients or patients undergoing liver transplant surgery.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04312958


Locations
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United States, California
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States, 94110
United States, Florida
University of Florida Health Shands Hospital
Gainesville, Florida, United States, 32608
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 98109
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905
United States, Virginia
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
HemoSonics LLC
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Responsible Party: HemoSonics LLC
ClinicalTrials.gov Identifier: NCT04312958    
Other Study ID Numbers: HEMCS-032
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by HemoSonics LLC:
Viscoelastic testing
Coagulation
Trauma
Liver Transplant
Quantra
QStat
Additional relevant MeSH terms:
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Hemorrhage
Wounds and Injuries
Pathologic Processes