Evaluation of the Clinical Performance of the Quantra System With the QPlus Cartridge in Pediatric Patients Undergoing Cardiovascular Procedures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Correlation of QPlus CT measurements to ROTEM Sigma INTEM CT
研究概览
简要总结
This study will evaluate the performance of the Quantra System with the QPlus Cartridge in pediatric patients undergoing cardiovascular procedures.
详细描述
Pediatric patients that require major sugical procedures, such as cardiac surgery, are especially vulnerable to perioperative coagulopathy due to age-related immaturity of the hemostatic system, exposure to hemodilution from circuit primes or intravenous volume loading, hypothermia during complex interventions, and the intrinsic bleeding of invasive cardiac procedures. These factors can produce clinically significant perioperative bleeding driven by platelet dysfunction, hypofibrinogenemia and other hemostatic defects. The Quantra System with the QPlus Cartridge is desinged to assess coagulation function of a whole blood sample at the point-of-care by measuring changes in the viscoelastic properties during clot formation. This multi-center study is aimed to demonstrate the performance of the QPlus Cartridge for its ability to aid in the evaluation of a pediatric patient's hemostatic status before, during and after cardiovascular procedures.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is <18 years of age.
- •Subject is undergoing a cardiovascular procedure OR subject underwent cardiovascular surgery and presents with acute bleeding or suspected hypocoagulation/hypercoagulation in a post-surgical unit.
- •Subject's parent(s) or guardian(s) has signed an informed consent form. If required, subject has signed an assent form.
排除标准
- •Corrected gestational age <37 weeks.
- •Subject is enrolled in a study that might confound the result of the proposed study.
- •Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks.
研究组 & 干预措施
Pediatric patients
Pediatric patients undergoing cardiovascular procedures
干预措施: Quantra System (Diagnostic Test)
结局指标
主要结局
Correlation of QPlus CT measurements to ROTEM Sigma INTEM CT
时间窗: 3 TIme Points: 1. 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Coagulation function assessed by Quantra and ROTEM sigma
Correlation of QPlus CTH measurements to ROTEM Sigma HEPTEM CT
时间窗: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Coagulation function assessed by Quantra and ROTEM sigma
Correlation of QPlus CS measurements to ROTEM Sigma EXTEM A10
时间窗: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Coagulation function assessed by Quantra and ROTEM sigma
Correlation of QPlus FCS measurements to ROTEM Sigma FIBTEM A10
时间窗: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Coagulation function assessed by Quantra and ROTEM sigma
Correlation of QPlus CT to TEG 6S CK-R
时间窗: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Coagulation function assessed by Quantra and TEG 6S
Correlation of QPlus CTH to TEG 6S CKH-R
时间窗: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Coagulation function assessed by Quantra and TEG 6S
Correlation of QPlus CS to TEG 6S CKH-MA
时间窗: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Coagulation function assessed by Quantra and TEG 6S
Correlation of QPlus FCS to TEG 6S FFH-MA
时间窗: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Coagulation function assessed by Quantra and TEG 6S
次要结局
未报告次要终点