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Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge

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ClinicalTrials.gov Identifier: NCT03912545
Recruitment Status : Completed
First Posted : April 11, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
HemoSonics LLC

Brief Summary:
This pilot study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QStat Cartridge in trauma patients or patients with OB hemorrhage.

Condition or disease Intervention/treatment
Blood Loss Massive Trauma Hemorrhage, Postpartum 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 obstetric hemorrhage 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 single-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to standard coagulation tests and comparable measures using conventional viscoelastic testing methods.


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Study Type : Observational
Actual Enrollment : 30 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 Obstetric Hemorrhage
Actual Study Start Date : March 4, 2019
Actual Primary Completion Date : July 11, 2019
Actual Study Completion Date : July 11, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Trauma patients
Subjects experiencing major trauma such that viscoelastic testing is performed as standard of care to assess coagulopathy.
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

Obstetric hemorrhage patients
Subjects experiencing obstetric hemorrhage such that viscoelastic testing is performed as standard of care is performed to assess coagulopathy.
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 and Clot Stiffness results to standard coagulation test results [ Time Frame: Upon arrival to emergency department (trauma subjects) or upon presentation with obstetric hemorrhage, prior to the administration of blood products or antifibrinolytics in parallel with samples collected for routine ROTEM analysis and laboratory assays ]
    Coagulation function assessed by Quantra and standard coagulation tests

  2. Comparison of Quantra Clot Time and Clot Stiffness results to ROTEM Delta results [ Time Frame: Upon arrival to emergency department (trauma subjects) or upon presentation with OB hemorrhage, prior to the administration of blood products or antifibrinolytics in parallel with samples collected for routine ROTEM analysis and laboratory assays ]
    Coagulation function assessed by Quantra and ROTEM Delta

  3. Comparison of Quantra Fibrinolysis results to ROTEM Delta results [ Time Frame: Upon arrival to emergency department (trauma subjects) or upon presentation with OB hemorrhage, prior to the administration of blood products or antifibrinolytics in parallel with samples collected for routine ROTEM analysis and laboratory assays ]
    Coagulation function assessed by Quantra and ROTEM Delta



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Potential study participants will be adult (>18 years) trauma patients or patients with OB hemorrhage such that viscoelastic testing is performed as standard of care to assess coagulopathy.
Criteria

Inclusion Criteria:

  • Subject is ≥ 18 years of age
  • Subject has one of the following conditions and is a candidate for a ROTEM test to be performed to access coagulopathy: trauma patient; patient with OB hemorrhage.

    • For trauma patients; subject must be experiencing major trauma (preferably requiring the highest level of team activation) with active bleeding or deemed at high risk of significant bleeding according to mechanism of injury.
    • For subjects experiencing OB hemorrhage, one of the following conditions must be met (to be confirmed):

      • Estimated blood loss during vaginal delivery is greater than 1000 mL
      • Estimated blood loss during cesarean delivery is greater than 1500 mL
      • Placental abruption with hemorrhage of any quantity blood loss
      • Clinically suspected disseminated intravascular coagulation (DIC)
      • Is under consideration for administration of tranexamic acid (TXA) for treatment of hemorrhage.
  • 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 presentation to trauma unit or during labor just prior to OB hemorrhage.
  • 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.

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): NCT03912545


Locations
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United States, Texas
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, United States, 79905
Sponsors and Collaborators
HemoSonics LLC

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Responsible Party: HemoSonics LLC
ClinicalTrials.gov Identifier: NCT03912545     History of Changes
Other Study ID Numbers: HEMCS-019
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by HemoSonics LLC:
Viscoelastic testing
Coagulation
Quantra
Hemostasis
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage