Detecting blood clots in patients with thromboembolism
In Vivo Detection of Circulating Clots in Patients With Thromboembolism
This study is testing a new device to see if it can better detect blood clots in patients with thromboembolic disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Arkansas Academic / other |
| Locations | 1 site (Little Rock, Arkansas) |
| Trial ID | NCT05301348 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of a novel device using Photoacoustic Flow Cytometry (PAFC) to detect circulating blood clots (CBCs) in patients diagnosed with thromboembolic disease. Current methods for detecting CBCs have poor sensitivity, especially when low numbers are present, leading to potential complications from undetected clots. By improving detection capabilities, this approach could enhance patient outcomes and reduce risks associated with thromboembolic conditions.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 18 and older with diagnosed venous or arterial thromboembolic disease.
Not a fit: Patients with conditions requiring immediate surgical intervention for thrombus removal or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better detection of blood clots, reducing complications and improving treatment outcomes for patients with thromboembolism.
How similar studies have performed: While there is limited data on the specific use of PAFC for this purpose, the study represents a novel approach to improving the detection of circulating blood clots.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Little Rock, Arkansas
- Univerisity of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Recruiting)
Study contacts
- Principal investigator: Sanjeeva Onteddu, MD — University of Arkansas
- Study coordinator: Sanjeeva Onteddu, MD
- Email: sronteddu@uams.edu
- Phone: 5016865135
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.