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

Launched by HEMOSONICS LLC · May 10, 2024

Keywords

ClinConnect Summary

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.

Gender

FEMALE

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