Clinical trial NCT06255496: QStat Cartridge in Obstetric Patients
Official title: Evaluation of the Clinical Performance of the Quantra® System With the QStat® Cartridge in Obstetric Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Blood Loss Massive
Post Partum Hemorrhage
Keywords: Quantra
Viscoelastic testing
Coagulation
Lead sponsor: HemoSonics LLC
Sponsor class: INDUSTRY
First posted: 2024-02-13
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturients 18 years or older who are at risk of experiencing an obstetric hemorrhage around the time of delivery.

Brief summary: This study will assess the performance of the Quantra System with the QStat Cartridge versus standard of care coagulation testing in pregnant women at risk of bleeding at delivery.

Detailed description: The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies including fibrinolytic defects. These patients include the tobstetric hemorrhage population. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system.

This multicenter, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to standard of care coagulation testing in pregnant women at risk of bleeding at delivery.

Eligibility criteria: Inclusion Criteria:

* Subject is greater than18 years.
* Subject is pregnant or at least 24 h postpartum
* Conventional coagulation tests and/or viscoelastic testing are ordered for concern of possible coagulopathy based on one or more clinical scenarios including hemorrhage, suspected or confirmed placental abruption, amniotic fluid embolism, or placenta accreta spectrum
* Subject or subject's LAR is willing to provide informed consent, either prospectively or by deferred consent.

Exclusion Criteria:

* Subject is younger than 18 years old.
* Subject or subject's LAR is unwilling or unable to provide informed consent, either prospectively or by deferred consent.
* Subject is incarcerated at the time of the study.
* Subject is currently enrolled in a distinct study that might confound the results of the proposed study
* Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks

Primary outcomes:
measure: Comparison of Quantra Clot Time to laboratory aPTT test results
timeFrame: At the time hemorrhage is suspected, anticipated within 24 hours after birth
measure: Comparison of Quantra Fibrinogen Contribution to Clot Stiffness to laboratory coagulation fibrinogen test results
timeFrame: At the time hemorrhage is suspected, anticipated within 24 hours after birth
measure: Comparison of Quantra Clot Time to ROTEM delta INTEM CT test results
timeFrame: At the time hemorrhage is suspected, anticipated within 24 hours after birth
measure: Comparison of Quantra Fibrinogen Contribution to Clot Stiffness to ROTEM delta FIBTEM test results
timeFrame: At the time hemorrhage is suspected, anticipated within 24 hours after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Medical Center
state: Oklahoma
city: Pittsburgh
country: United States
facility: Magee Womens Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Parkland Health
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: