QStat Cartridge in Obstetric Patients
- Conditions
- Post Partum HemorrhageBlood Loss Massive
- Interventions
- Diagnostic Test: Quantra Hemostasis Analyzer with the QStat Cartridge
- Registration Number
- NCT06255496
- Lead Sponsor
- HemoSonics LLC
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 300
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Obstetric Patients Quantra Hemostasis Analyzer with the QStat Cartridge Obstetric patient population at risk of experiencing excessive bleeding around the time of delivery
- Primary Outcome Measures
Name Time Method Comparison of Quantra Clot Time to ROTEM delta INTEM CT test results At the time hemorrhage is suspected, anticipated within 24 hours after birth Coagulation function assessed by Quantra Clot Time (CT, sec) and ROTEM INTEM CT (sec) test
Comparison of Quantra Fibrinogen Contribution to Clot Stiffness to laboratory coagulation fibrinogen test results At the time hemorrhage is suspected, anticipated within 24 hours after birth Coagulation function assessed by Quantra Fibrinogen Contribution to Clot Stiffness (FCS, hPa) and Clauss fibrinogen (mg/dL) test
Comparison of Quantra Fibrinogen Contribution to Clot Stiffness to ROTEM delta FIBTEM test results At the time hemorrhage is suspected, anticipated within 24 hours after birth Coagulation function assessed by Quantra Fibrinogen Contribution to Clot Stiffness (FCS, hPa) and ROTEM FIBTEM (mm) test
Comparison of Quantra Clot Time to laboratory aPTT test results At the time hemorrhage is suspected, anticipated within 24 hours after birth Coagulation function assessed by Quantra Clot Time (CT, sec) and activated partial thromboplastin (aPTT, sec) test
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Magee Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Parkland Health
🇺🇸Dallas, Texas, United States
Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of Oklahoma Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States