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In Vivo Detection of Circulating Clots in Patients With Thromboembolism

ConditionThromboembolism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Arkansas

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Photoacoustic Flow Cytometry

    Device

    Detection of circulating blood clots

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: ProcedureExperimental treatment 1 intervention

Trial outcomes

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

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

Time frame
30 days
2

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.

Time frame
30 days

Secondary outcomes

1

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.

Time frame
30 days
2

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.

Time frame
30 days
3

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

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Arkansas

Lead sponsor

Source ClinicalTrials.gov
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