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NCT Number: NCT05301348

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univerisity of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location status: Recruiting

Location contact

Sanjeeva Onteddu, M.D.

CONTACT

[email protected]

501-686-5135

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photoacoustic Flow Cytometry

Device

Detection of circulating blood clots

Primary outcomes

  1. Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Positive PA peaks

    Time frame: 30 days

    Measurement of in vivo CBC-associated positive PA peaks in a signal trace of patients who have been diagnosed with conventional methods.

  2. Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Negative PA peaks

    Time frame: 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 outcomes

  1. Relationship between PA peaks and circulating blood clots

    Time frame: 30 days

    PAFC will be compared with the fibrin degradation fragment D-dimer to indicate the presence of a blood clot undergoing dissolution.

  2. Safety of the PAFC method - skin sensitivity

    Time frame: 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.

  3. Safety of the PAFC method - change in skin property

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sanjeeva Onteddu, MD

CONTACT

[email protected]

5016865135

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Mar 29, 2022
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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