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

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: NCT03912545
• Other study ID #: HEMCS-019
• Status: Completed
• Start date: March 4, 2019
• Est. completion date: July 11, 2019

Study information

• Verified date: September 2019
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 11, 2019
• Est. primary completion date: July 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss Massive
• Hemorrhage
• Hemorrhage, Postpartum
• Postpartum Hemorrhage
• Trauma

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	Texas Tech University Health Sciences Center El Paso	El Paso	Texas

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 Quantra Clot Time and Clot Stiffness results to standard coagulation test results	Coagulation function assessed by Quantra and standard coagulation tests	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
Primary	Comparison of Quantra Clot Time and Clot Stiffness results to ROTEM Delta results	Coagulation function assessed by Quantra and ROTEM Delta	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
Primary	Comparison of Quantra Fibrinolysis results to ROTEM Delta results	Coagulation function assessed by Quantra and ROTEM Delta	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