RecruitingNot ApplicableNCT05301348

In Vivo Detection of Circulating Clots in Patients With Thromboembolism


Sponsor

University of Arkansas

Enrollment

30 participants

Start Date

Jul 26, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria11

  • 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

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Interventions

DEVICEPhotoacoustic Flow Cytometry

Detection of circulating blood clots


Locations(1)

Univerisity of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

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NCT05301348


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