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

• Conditions: Obstetric Hemostasis; Coagulation
• Interventions: Diagnostic Test: Quantra System

• Registration Number: NCT06415760
• Lead Sponsor: HemoSonics LLC

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

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 Timeline

• Study Start: 2024-05-07
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-10
• Study First Posted: 2024-05-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-03-30
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obstetric Patients	Quantra System	Adult pregnant women in their third trimester of prenancy with no prenatal risk factors and an uncomplicated pregnancy.

Primary Outcome Measures

Name	Time	Method
Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter	Baseline, determined from a single blood draw	Reference range intervals for FCS for pregnant women in third trimester
Reference range intervals for measurement of Platelet Contribution (PCS) parameter	Baseline, determined from a single blood draw	Reference range intervals for PCS for pregnant women in third trimester
Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter	Baseline, determined from a single blood draw	Reference range intervals for CSL for pregnant women in third trimester
Reference range intervals for measurement of Clot Stiffness (CS) parameter	Baseline, determined from a single blood draw	Reference range intervals for CS for pregnant women in third trimester
Reference range intervals for measurement of Clot Time (CT) parameter	Baseline, determined from a single blood draw	Reference range intervals for CT for pregnant women in third trimester

Trial Locations

Locations (2)

University of Florida Medicine; 🇺🇸 Gainesville, Florida, United States

Unified Womens Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States