Evaluation of the Quantra QStat System in Obstetric Patients

HemoSonics LLC50 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Blood Loss Massive Post Operative Hemorrhage

Interventions

Quantra SystemDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University Hospital

Durham, North Carolina, 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 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

Time frame: 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

Time frame: 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

Time frame: At the time the OB hemorrhage protocol is activated, anticipated with 24 hours after birth

Data from ClinicalTrials.gov

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