In Vivo Detection of Circulating Clots in Patients With Thromboembolism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Negative PA peaks
研究概览
简要总结
Subjects with thromboembolic disease or at high-risk for thromboembolic conditions diagnosed with ultrasound or other standard of care techniques will be recruited to estimate the feasibility of a device to detect in vivo CBCs.
详细描述
There are no current gold standards to detect circulating blood clots. The sensitivity of most current methods to detect CBCs is poor when low numbers are present in the host. A novel method of detecting circulating blood clots, PAFC, may improve detection of CBCs and, if so, ultimately may reduce complications related to previously undetected clots.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, 18 years old and older.
- •Evidence of current venous or arterial thromboembolic disease diagnosed by standard of care clinical, radiographic, or laboratory testing or acute ischemic stroke.
- •Informed consent provided by the subject.
排除标准
- •Pulmonary embolus with a need for mechanical ventilation or other ventilator support (may be on oxygen delivered by nasal cannula or mask at an FiO2 of ≤ 0.40)
- •Acute coronary syndrome (including unstable angina)
- •Significant cardiac arrhythmia (may have atrial fibrillation controlled with medication)
- •Intracardiac thrombus
- •Any embolus or thrombus requiring vascular surgery or interventional radiology to attempt acute embolectomy or thrombectomy
- •Sickle cell disease with vaso-occlusive crisis
- •Sepsis or life-threatening infection
- •Traumatic injury requiring hospitalization (within 30 days prior to enrollment)
- •Pregnancy or breastfeeding
- •Severe mental illness
- •Other conditions deemed by the investigators to put the subject at greater risk
研究组 & 干预措施
Procedure
Subjects will receive PAFC procedure
干预措施: Photoacoustic Flow Cytometry (Device)
结局指标
主要结局
Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Negative PA peaks
时间窗: 30 days
Measurement of in vivo CBC-associated negative PA peaks in a signal trace of patients who have been diagnosed with conventional methods.
Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Positive PA peaks
时间窗: 30 days
Measurement of in vivo CBC-associated positive PA peaks in a signal trace of patients who have been diagnosed with conventional methods.
次要结局
- Relationship between PA peaks and circulating blood clots(30 days)
- Safety of the PAFC method - change in skin property(30 days)
- Safety of the PAFC method - skin sensitivity(30 days)