QStat in Trauma and Obstetric Hemorrhage

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385953
• Other study ID #: HEMCS-030
• Status: Completed
• Start date: December 10, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2020
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QStat Cartridge in trauma patients and obstetric patients with postpartum hemorrhage.

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. This includes the trauma, obstetric hemorrhage 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 prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to comparable measures using conventional viscoelastic testing methods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is = 18 years of age

• Subject is a trauma patient 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.and is a candidate for a ROTEM test to be performed to access coagulopathy.

OR

-Subject is an obstetric patient experiencing post-partum hemorrhage based on one of the following conditions: estimated blood loss during delivery >1000 mL; placental abruption with hemorrhage of any quantity; clinically suspected DIC; pregnancy resulted in fetal demise with hemorrhage of any quantity; or is under consideration for administration of tranexamic acid for treatment of hemorrhage.

Exclusion Criteria:

• Subject is younger than 18 years of age

• Subject presents for a procedure intended to abort a pregnancy for reasons other than medical necessity

• Subject is known to have received antifibrinolytic therapy immediately prior to presentation to trauma unit

• 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.

Related Conditions & MeSH terms

• Blood Loss Massive
• Hemorrhage
• Post Partum Hemorrhage
• Postpartum Hemorrhage
• Trauma
• Wounds and Injuries

Intervention

Diagnostic Test:
• Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital and Trauma Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
HemoSonics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the Quantra results to corresponding ROTEM Delta results	Coagulation function assessed by Quantra and ROTEM delta	Upon arrival to emergency department
Primary	Comparison of the Quantra results to corresponding ROTEM Delta results	Coagulation function assessed by Quantra and ROTEM delta	At the time of hemorrhage for obstetric patients