Quantra QStat in Trauma and Liver Transplant

April 28, 2023 updated by: HemoSonics LLC

Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma and Liver Transplantation

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
397

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • Zuckerberg San Francisco General Hospital and Trauma Center
    • Colorado
      • Denver, Colorado, United States, 28037
        • University of Colorado
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida Health Shands Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 98109
        • University of Michigan Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Medical Center
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • El Paso, Texas, United States, 79905
        • Texas Tech University Health Sciences Center
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Potential study participants will be adult (>18 years) trauma patients or patients undergoing liver transplant surgery.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Quantra QStat Cartridge

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Upon arrival of trauma subject to the emergency department
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
Baseline, immediately before the start of liver transplant surgery
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
During anhepatic phase of liver transplant surgery
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
During post-reperfusion phase of liver transplant surgery
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
Upon arrival of trauma subject to the emergency department
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
Baseline, immediately before the start of liver transplant surgery
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
During anhepatic phase of liver transplant surgery
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
During post-reperfusion phase of liver transplant surgery
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
Upon arrival of trauma subject to the emergency department
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
Baseline, immediately before the start of liver transplant surgery
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
During anhepatic phase of liver transplant surgery
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
During post-reperfusion phase of liver transplant surgery
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
Upon arrival of trauma subject to the emergency department
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
Baseline, immediately before the start of liver transplant surgery
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
During anhepatic phase of liver transplant surgery
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
During post-reperfusion phase of liver transplant surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HemoSonics LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HEMCS-032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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