In Vivo Detection of Circulating Clots in Patients With Thromboembolism
Study Details
Study Description
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 device to detect in vivo CBCs.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Procedure Subjects will receive PAFC procedure |
Device: Photoacoustic Flow Cytometry
Detection of circulating blood clots
|
Outcome Measures
Primary Outcome Measures
- Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Positive PA peaks [30 days]
Measurement of in vivo CBC-associated positive 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 - Negative PA peaks [30 days]
Measurement of in vivo CBC-associated negative PA peaks in a signal trace of patients who have been diagnosed with conventional methods.
Secondary Outcome Measures
- Relationship between PA peaks and circulating blood clots [30 days]
PAFC will be compared with the fibrin degradation fragment D-dimer to indicate the presence of a blood clot undergoing dissolution.
- Safety of the PAFC method - skin sensitivity [30 days]
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.
- Safety of the PAFC method - change in skin property [30 days]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
- Evidence of current venous or arterial thromboembolic disease diagnosed by standard of care clinical, radiographic, or laboratory testing.
Exclusion Criteria:
-
Treatment with anticoagulant therapy (except aspirin) for longer than 24 hours (within 30 days prior to consideration for inclusion)
-
pulmonary embolus
-
acute coronary syndrome, acute stroke, significant cardiac arrhythmia, intracardiac thrombus, any embolus or thrombus requiring vascular surgery or interventional radiology to attempt acute embolectomy or thrombectomy
-
sickle cell disease
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sepsis, traumatic injury, pregnancy or breastfeeding
-
severe mental illness
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Univerisity of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
Sponsors and Collaborators
- University of Arkansas
Investigators
- Principal Investigator: Kyla R Shelton, MD, MS, University of Arkansas
- Study Director: Jonathan A Young, University of Arkansas
Study Documents (Full-Text)
None provided.More Information
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.
- Cushman M. Epidemiology and risk factors for venous thrombosis. Semin Hematol. 2007 Apr;44(2):62-9. Review.
- 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.
- 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. Review.
- Heit JA. Venous thromboembolism: disease burden, outcomes and risk factors. J Thromb Haemost. 2005 Aug;3(8):1611-7. Review.
- 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.
- 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.
- 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.
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