Pilot Study Evaluating the Clinical Performance of the Quantra With the QStat Cartridge at the Point-of-care in Obstetric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Comparison of Quantra Clot Time to laboratory aPTT test results
研究概览
简要总结
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.
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 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.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 laboratory aPTT test results
时间窗: At the time the OB hemorrhage protocol is activated, anticipated with 24 hours after birth
Coagulation function assessed by Quantra Clot Time (CT, sec) and activated partial thromboplastin (aPTT, sec) test
Comparison of Quantra Fibrinogen Contribution to Clot Stiffness to laboratory coagulation fibrinogen test results
时间窗: At the time the OB hemorrhage protocol is activated, anticipated with 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 Clot Time to ROTEM delta INTEM CT test results
时间窗: At the time the OB hemorrhage protocol is activated, anticipated with 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 ROTEM delta FIBTEM test results
时间窗: At the time the OB hemorrhage protocol is activated, anticipated with 24 hours after birth
Coagulation function assessed by Quantra Fibrinogen Contribution to Clot Stiffness (FCS, hPa) and ROTEM FIBTEM (mm) test
次要结局
未报告次要终点