Evaluation of the Clinical Performance of the Quantra® System With the QStat® Cartridge in Obstetric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 296
- 试验地点
- 6
- 主要终点
- Comparison of Quantra Clot Time to ROTEM delta INTEM CT test results
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Comparison of Quantra Clot Time to ROTEM delta INTEM CT test results
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点