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

NCT03912545 | Completed FDA Device

• 1 other identifier: HEMCS-019
• 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 or patients with OB hemorrhage.

Conditions

Blood Loss Massive; Trauma; Hemorrhage, Postpartum

Keywords

Viscoelastic testing; Coagulation; Quantra; Hemostasis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Trauma patients

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

Diagnostic Test: Quantra System

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

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

Obstetric hemorrhage patients; 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 or patients with OB hemorrhage such that viscoelastic testing is performed as standard of care to assess coagulopathy.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• HemoSonics LLC: lead

Study Sites (1)

Texas Tech University Health Sciences Center El Paso

El Paso, Texas, 79905, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Postpartum Hemorrhage; Thrombosis

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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 9, 2019
• First Posted: April 11, 2019
• Study Start: March 4, 2019
• Primary Completion: July 11, 2019
• Study Completion: July 11, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)