Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients

NCT06415760 | Completed FDA Device

• 1 other identifier: HEMCS-047
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 3

Brief Summary

This study will determine reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge in the last trimester of non-laboring pregnant women with an uncomplicated pregnancy

Conditions

Obstetric Hemostasis; Coagulation

Keywords

Quantra; Viscoelastic testing; Coagulation

Outcome Measures

Primary Outcomes (5)

• Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter

  Reference range intervals for CSL for pregnant women in third trimester

  Baseline, determined from a single blood draw

• Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter

  Reference range intervals for FCS for pregnant women in third trimester

  Baseline, determined from a single blood draw

• Reference range intervals for measurement of Platelet Contribution (PCS) parameter

  Reference range intervals for PCS for pregnant women in third trimester

  Baseline, determined from a single blood draw

• Reference range intervals for measurement of Clot Stiffness (CS) parameter

  Reference range intervals for CS for pregnant women in third trimester

  Baseline, determined from a single blood draw

• Reference range intervals for measurement of Clot Time (CT) parameter

  Reference range intervals for CT for pregnant women in third trimester

  Baseline, determined from a single blood draw

Study Arms (1)

Obstetric Patients

Adult pregnant women in their third trimester of prenancy with no prenatal risk factors and an uncomplicated pregnancy.

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: QStat Cartridge

Obstetric Patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult pregnant women 18 years of age or older in their third trimester of pregnancy with no prenatal risk factors and an uncomplicated pregnancy.

You may qualify if:

• Subject is female, age 18 to 45 years old.
• Subject is pregnant with a single fetus and duration of pregnancy is \>28weeks
• Subject is willing to participate and has provided informed consent.

You may not qualify if:

• Subject has a history of a coagulation disorder (including excessive bleeding, thrombosis, VWD, or any factor deficiencies).
• Subject has taken medications known to alter coagulation during pregnancy including heparin, warfarin/Coumadin®, antiplatelet drugs including Plavix® or aspirin at a dose greater than 81 mg/day, Xarelto® or Eliquis®, or other anticoagulants.
• Subject has experienced one or more complications during pregnancy such as gestational diabetes, high blood pressure, pre-eclampsia or eclampsia, hypovolemia or pre-term labor.
• Subject had a blood transfusion during pregnancy.
• Subject has a history of smoking/vaping during pregnancy

Sponsors & Collaborators

• HemoSonics LLC: lead

Study Sites (3)

University of Florida Medicine

Gainesville, Florida, 32611, United States

Location

Unified Womens Clinical Research

Raleigh, North Carolina, 27612, United States

Location

Unified Womens Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

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: May 10, 2024
• First Posted: May 16, 2024
• Study Start: May 7, 2024
• Primary Completion: April 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)