QStat in Trauma and Obstetric Hemorrhage

NCT ID: NCT04385953

Last Updated: 2020-09-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2020-08-01

Brief 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.

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. 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.

Conditions

Blood Loss Massive; Trauma; Post Partum Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Trauma patients

Subject experiencing major trauma

Quantra System

Intervention Type: DIAGNOSTIC_TEST

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

Obstetric patients

Obstetric patient with postpartum hemorrhage

Quantra System

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Quantra System

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Quantra QStat Cartridge

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HemoSonics LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, United States

Countries

United States

Other Identifiers

HEMCS-030

Identifier Type: -

Identifier Source: org_study_id