Clinical trial NCT06415760: Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients
Official title: Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Obstetric Hemostasis
Coagulation
Keywords: Quantra
Viscoelastic testing
Coagulation
Lead sponsor: HemoSonics LLC
Sponsor class: INDUSTRY
First posted: 2024-05-16
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter
timeFrame: Baseline, determined from a single blood draw
measure: Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter
timeFrame: Baseline, determined from a single blood draw
measure: Reference range intervals for measurement of Platelet Contribution (PCS) parameter
timeFrame: Baseline, determined from a single blood draw
measure: Reference range intervals for measurement of Clot Stiffness (CS) parameter
timeFrame: Baseline, determined from a single blood draw
measure: Reference range intervals for measurement of Clot Time (CT) parameter
timeFrame: Baseline, determined from a single blood draw
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Medicine
state: Florida
city: Raleigh
country: United States
facility: Unified Womens Clinical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Womens Clinical Research
state: North Carolina
Study officials:
References: