In Vivo Detection of Circulating Clots in Patients With Thromboembolism

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.

Study Overview

• Status: Recruiting
• Conditions: Thromboembolism
• Intervention / Treatment: Device: Photoacoustic Flow Cytometry

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 detecting circulating blood clots, PAFC, may improve detection of CBCs and, if so, ultimately may reduce complications related to previously undetected clots.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sanjeeva Onteddu, MD; Phone Number: 5016865135; Email: sronteddu@uams.edu

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • Univerisity of Arkansas for Medical Sciences
      • Contact: Sanjeeva Onteddu, M.D.; Phone Number: 501-686-5135; Email: sronteddu@uams.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Procedure; Subjects will receive PAFC procedure	Device: Photoacoustic Flow Cytometry; Detection of circulating blood clots

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Positive PA peaks	Measurement of in vivo CBC-associated positive PA peaks in a signal trace of patients who have been diagnosed with conventional methods.	30 days
Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Negative PA peaks	Measurement of in vivo CBC-associated negative PA peaks in a signal trace of patients who have been diagnosed with conventional methods.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between PA peaks and circulating blood clots	PAFC will be compared with the fibrin degradation fragment D-dimer to indicate the presence of a blood clot undergoing dissolution.	30 days
Safety of the PAFC method - skin sensitivity	The safety of the PAFC device through estimation of the sensitivity of the individual's skin to laser radiation will be indicated by a possible warming feeling or tingling sensation.	30 days
Safety of the PAFC method - change in skin property	The safety of the PAFC device through estimation of the change to the skin's property after laser exposure measured by appearance of possible red spots in the irradiated local area	30 days

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Study Director: Jonathan A Young, University of Arkansas; Principal Investigator: Sanjeeva Onteddu, MD, University of Arkansas

Publications and helpful links

General Publications

• Anderson FA Jr, Wheeler HB, Goldberg RJ, Hosmer DW, Patwardhan NA, Jovanovic B, Forcier A, Dalen JE. A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT Study. Arch Intern Med. 1991 May;151(5):933-8.
• Dressler DK. Death by clot: acute coronary syndromes, ischemic stroke, pulmonary embolism, and disseminated intravascular coagulation. AACN Adv Crit Care. 2009 Apr-Jun;20(2):166-76. doi: 10.1097/NCI.0b013e3181a0b5e8.
• Nedosekin DA, Sarimollaoglu M, Galanzha EI, Sawant R, Torchilin VP, Verkhusha VV, Ma J, Frank MH, Biris AS, Zharov VP. Synergy of photoacoustic and fluorescence flow cytometry of circulating cells with negative and positive contrasts. J Biophotonics. 2013 May;6(5):425-34. doi: 10.1002/jbio.201200047. Epub 2012 Aug 20.
• Juratli MA, Menyaev YA, Sarimollaoglu M, Melerzanov AV, Nedosekin DA, Culp WC, Suen JY, Galanzha EI, Zharov VP. Noninvasive label-free detection of circulating white and red blood clots in deep vessels with a focused photoacoustic probe. Biomed Opt Express. 2018 Oct 23;9(11):5667-5677. doi: 10.1364/BOE.9.005667. eCollection 2018 Nov 1.
• Cushman M. Epidemiology and risk factors for venous thrombosis. Semin Hematol. 2007 Apr;44(2):62-9. doi: 10.1053/j.seminhematol.2007.02.004.
• Heit JA. Venous thromboembolism: disease burden, outcomes and risk factors. J Thromb Haemost. 2005 Aug;3(8):1611-7. doi: 10.1111/j.1538-7836.2005.01415.x.
• Juratli MA, Menyaev YA, Sarimollaoglu M, Siegel ER, Nedosekin DA, Suen JY, Melerzanov AV, Juratli TA, Galanzha EI, Zharov VP. Real-Time Label-Free Embolus Detection Using In Vivo Photoacoustic Flow Cytometry. PLoS One. 2016 May 26;11(5):e0156269. doi: 10.1371/journal.pone.0156269. eCollection 2016.
• Galanzha EI, Sarimollaoglu M, Nedosekin DA, Keyrouz SG, Mehta JL, Zharov VP. In vivo flow cytometry of circulating clots using negative photothermal and photoacoustic contrasts. Cytometry A. 2011 Oct;79(10):814-24. doi: 10.1002/cyto.a.21106. Epub 2011 Aug 16.
• Galanzha EI, Zharov VP. Photoacoustic flow cytometry. Methods. 2012 Jul;57(3):280-96. doi: 10.1016/j.ymeth.2012.06.009. Epub 2012 Jun 26.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thromboembolism
• Other Study ID Numbers: 239347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes