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

Coagulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06415760
• Other study ID #: HEMCS-047
• Status: Enrolling by invitation
• Start date: May 7, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: May 2024
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: October 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Coagulation

Intervention

Diagnostic Test:
• Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care

Locations

Country	Name	City	State
United States	Unified Womens Clinical Research	Raleigh	North Carolina
United States	Unified Womens Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
HemoSonics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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