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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Coagulation; Obstetric Hemostasis
• Intervention / Treatment: Diagnostic test: Quantra System

Detailed Description

During pregnancy, there is a progressive shift of hemostasis toward a hypercoagulable state that is protective against postpartum hemorrhage. To assess the clinical utility of the Quantra System in high-risk OB patients during delivery, it is important to understand how the normal physiological changes of pregnancy impact Quantra results. 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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Unified Womens Clinical Research
    • Winston-Salem, North Carolina, United States, 27103
      • Unified Womens Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obstetric Patients; Adult pregnant women in their third trimester of prenancy with no prenatal risk factors and an uncomplicated pregnancy.	Diagnostic test: Quantra System; Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care; Other Names: QStat Cartridge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: HemoSonics LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Coagulation; Quantra; Viscoelastic testing
• Other Study ID Numbers: HEMCS-047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes