Evaluation of the Quantra QStat System in Obstetric Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study Evaluating the Clinical Performance of the Quantra With the QStat Cartridge at the Point-of-care in Obstetric Patients

Conditions
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Blood Loss Massive, Post Operative Hemorrhage

Intervention / Treatment
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* Device: Quantra System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obstetric Patients<br>Obstetric patient population experiencing excessive bleeding around the time of delivery | Device: Quantra System<br>* Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.<br>* Other names: QStat Cartridge;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At the time the OB hemorrhage protocol is activated, anticipated with 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 | At the time the OB hemorrhage protocol is activated, anticipated with 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 | At the time the OB hemorrhage protocol is activated, anticipated with 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 | At the time the OB hemorrhage protocol is activated, anticipated with 24 hours after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quantra, Viscoelastic testing, Coagulation