Clinical trial NCT05875987: Evaluation of the Quantra QStat System in Obstetric Patients
Official title: Pilot Study Evaluating the Clinical Performance of the Quantra With the QStat Cartridge at the Point-of-care in Obstetric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Loss Massive
Post Operative Hemorrhage
Keywords: Quantra
Viscoelastic testing
Coagulation
Lead sponsor: HemoSonics LLC
Sponsor class: INDUSTRY
First posted: 2023-05-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pparturients 18 years or older who experience an obstetric hemorrhage around the time of delivery or cumulatively over 24h after delivery or unstable vital signs or clinical signs of a coagulopathy managed with activation of the stage 2 OB hemorrhage protocol.

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

Eligibility criteria: Inclusion Criteria:

* Subject is \> 18 years.
* Subject is pregnant or at least 24 h postpartum
* Subject is fluent in English language.
* Subject is experiencing significant bleeding resulting in activation of the stage 2 OB hemorrhage protocol as defined by blood loss ≥1500ml at delivery or within the first 24 hours after delivery, and/or is hemodynamically unstable and/or is experiencing increased abnormal bleeding not responsive to OB stage 1 hemorrhage resuscitation.
* Subject or subject's legally authorized representative (LAR) is willing to provide informed consent, either prospectively or by deferred consent.

Exclusion Criteria:

* 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 the OB hemorrhage protocol is activated, anticipated with 24 hours after birth
measure: Comparison of Quantra Fibrinogen Contribution to Clot Stiffness to laboratory coagulation fibrinogen test results
timeFrame: At the time the OB hemorrhage protocol is activated, anticipated with 24 hours after birth
measure: Comparison of Quantra Clot Time to ROTEM delta INTEM CT test results
timeFrame: At the time the OB hemorrhage protocol is activated, anticipated with 24 hours after birth
measure: Comparison of Quantra Fibrinogen Contribution to Clot Stiffness to ROTEM delta FIBTEM test results
timeFrame: At the time the OB hemorrhage protocol is activated, anticipated with 24 hours after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
References: