Status:
RECRUITING
In Vivo Detection of Circulating Clots in Patients With Thromboembolism
Lead Sponsor:
University of Arkansas
Conditions:
Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 dev...
Detailed Description
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 detect...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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 Criteria
- 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
Exclusion
Key Trial Info
Start Date :
July 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05301348
Start Date
July 26 2023
End Date
January 31 2026
Last Update
February 26 2025
Active Locations (1)
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1
Univerisity of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205