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

NCT03934983 | Completed FDA Device

• 1 other identifier: HEMCS-021
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Loss Massive; Trauma

Keywords

Viscoelastic testing; Coagulation; Quantra; Hemostasis

Outcome Measures

Primary Outcomes (5)

• Comparison of the Quantra Clot Time results to standard coagulation test results

  Coagulation function assessed by Quantra and standard coagulation tests

  Upon arrival to emergency department

• Comparison of the Quantra Clot Stiffness results to standard coagulation test results

  Coagulation function assessed by Quantra and standard coagulation tests

  Upon arrival to emergency department

• Comparison of the Quantra Clot Time results to ROTEM Delta results

  Coagulation function assessed by Quantra and ROTEM delta

  Upon arrival to emergency department

• Comparison of the Quantra Clot Stiffness results to ROTEM Delta results

  Coagulation function assessed by Quantra and ROTEM delta

  Upon arrival to emergency department

• Comparison of the Quantra Fibrinolysis results to ROTEM Delta results

  Coagulation function assessed by Quantra and ROTEM delta

  Upon arrival to emergency department

Study Arms (1)

Trauma patients

Subject experiencing major trauma such that viscoelastic testing is performed as standard of care to assess coagulopathy.

Diagnostic Test: Quantra System

Interventions

Quantra System DIAGNOSTIC_TEST

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

Also known as: Quantra QStat Cartridge

Trauma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential study participants will be adult (\>18 years) trauma patients where visicoelastic testing is performed as standard of care to assess coagulopathy.

You may qualify if:

• Subject is ≥ 18 years of age
• Subject is a trauma patient and is a candidate for a ROTEM test to be performed to access coagulopathy
• 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.
• Subject is willing to participate, and is willing to consent (either prospectively or by deferred consent)

You may not qualify if:

• Subject is younger than 18 years of age
• Subject weighs less than 110 pounds
• Subject is known to have received antifibrinolytic therapy immediately prior to presentation to trauma unit
• 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.

Sponsors & Collaborators

• HemoSonics LLC: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2019
• First Posted: May 2, 2019
• Study Start: March 28, 2019
• Primary Completion: January 29, 2020
• Study Completion: January 31, 2020
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)