In Vivo Detection of Circulating Clots in Patients With Thromboembolism

NCT ID: NCT05301348

Last Updated: 2025-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-26

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Thromboembolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Procedure

Subjects will receive PAFC procedure

Group Type EXPERIMENTAL

Photoacoustic Flow Cytometry

Intervention Type DEVICE

Detection of circulating blood clots

Interventions

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Photoacoustic Flow Cytometry

Detection of circulating blood clots

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanjeeva Onteddu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Jonathan A Young

Role: STUDY_DIRECTOR

University of Arkansas

Locations

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Univerisity of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sanjeeva Onteddu, MD

Role: CONTACT

5016865135

Facility Contacts

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Sanjeeva Onteddu, M.D.

Role: primary

501-686-5135

References

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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.

Reference Type BACKGROUND
PMID: 19411875 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22903924 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30460154 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17433897 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16102026 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2025141 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27227413 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21976458 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22749928 (View on PubMed)

Other Identifiers

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239347

Identifier Type: -

Identifier Source: org_study_id

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