QStat Cartridge in Obstetric Patients

HemoSonics LLC296 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

296

Conditions

Blood Loss Massive Post Partum Hemorrhage

Interventions

Quantra Hemostasis Analyzer with the QStat CartridgeDIAGNOSTIC_TEST

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (6)

University of Rochester Medical Center

Rochester, New York, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

University of Oklahoma Medical Center

Oklahoma City, Oklahoma, United States

Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Comparison of Quantra Clot Time to laboratory aPTT test results

Coagulation function assessed by Quantra Clot Time (CT, sec) and activated partial thromboplastin (aPTT, sec) test

Time frame: At the time hemorrhage is suspected, anticipated within 24 hours after birth

Comparison of Quantra Fibrinogen Contribution to Clot Stiffness to laboratory coagulation fibrinogen test results

Coagulation function assessed by Quantra Fibrinogen Contribution to Clot Stiffness (FCS, hPa) and Clauss fibrinogen (mg/dL) test

Time frame: At the time hemorrhage is suspected, anticipated within 24 hours after birth

Comparison of Quantra Clot Time to ROTEM delta INTEM CT test results

Coagulation function assessed by Quantra Clot Time (CT, sec) and ROTEM INTEM CT (sec) test

Time frame: At the time hemorrhage is suspected, anticipated within 24 hours after birth

Comparison of Quantra Fibrinogen Contribution to Clot Stiffness to ROTEM delta FIBTEM test results

Coagulation function assessed by Quantra Fibrinogen Contribution to Clot Stiffness (FCS, hPa) and ROTEM FIBTEM (mm) test

Time frame: At the time hemorrhage is suspected, anticipated within 24 hours after birth

Data from ClinicalTrials.gov

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