Detecting Circulating Emboli in Patients With Acute Venous Thromboembolism

Venous Thromboembolism Clinical Trial

— PAFC  

Official title:

Detecting Circulating Emboli in Patients With Acute Venous Thromboembolism Using in Vivo Photoacoustic Flow Cytometry (PAFC)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02735759
• Other study ID #: 205341
• Status: Withdrawn
• Phase: N/A
• Start date: July 2018
• Est. completion date: December 2019

Study information

• Verified date: July 2018
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to further evaluate and adjust the photoacoustic flow cytometry device and its use in detecting circulating emboli.

Study Design: Cohort 1: Normal healthy volunteers will be enrolled to further adjust the device settings. Cohort 2: Use the Phatoacoustic flow cytometry (PAFC) to detect circulating emboli in vivo in patients with venous thromboembolism at diagnosis, during and after anticoagulation therapy.

Description:

Laser beam from the investigational device Phatoacoustic flow cytometry PAFC will be applied to skin and underlying blood vessels. The optical and ultrasound signal will be collected for analysis. On each tested vessel, we will estimate the vessels diameter (using optical or/and ultrasound imaging). The subject's skin pigmentation will be classified as light, medium, or dark. A photoacoustic (PA) contrast will be considered usable for detection of circulating emboli if the photoacoustic signal from the vessels is more than 1.3-fold higher than the photoacoustic signal from surrounding tissue. The device for subjects enrolled on cohort 2 will be completed on day 0 (immediately after venous thromboembolism diagnosis and prior to anticoagulation therapy), day 7 ± 3 days after initiation of anticoagulation therapy, one week ± 3 days after completion of planned anticoagulation therapy and one month ± 3 days after completion of planned anticoagulation therapy. Anticoagulation therapy is part of the patient's normal standard of care and is not part of this study however data from what therapy was received may be captured. D-dimer test will be performed on each time point as part of their normal standard of care however if the D-dimer test is not ordered as part of the standard of care it will be required for the study.. Patients will then be followed in hematology clinic to monitor the venous thromboembolism recurrence every 3 months for one year.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria Cohort 1:

• Age 18 years and older

• Willing to adhere to protocol.

• Signed informed consent

Exclusion Criteria Cohort 1:

• Unable to provide informed consent.

• History of venous thromboembolism.

• Currently receiving anticoagulant therapy.

Inclusion Criteria Cohort 2:

• Ages 18 years and older

• Confirmed new diagnosis of acute venous thromboembolism.

• performance status of equal to or less than 2.

• Able to receive anticoagulation therapy.

• Willing to adhere to specific protocol requirements.

• Signed informed consent.

Exclusion Criteria Cohort 2:

• Life threatening venous thromboembolism.

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Device:
• Photoacoustic flow cytometry device
The device for subjects enrolled on cohort 2 will be completed on day 0 (immediately after venous thromboembolism diagnosis and prior to anticoagulation therapy), day 7 ± 3 days after initiation of anticoagulation therapy, one week ± 3 days after completion of planned anticoagulation therapy and one month ± 3 days after completion of planned anticoagulation therapy. Anticoagulation therapy is part of the patient's normal standard of care and is not part of this study however data from what therapy was received may be captured. Patients will then be followed in hematology clinic to monitor the venous thromboembolism recurrence every 3 months for one year.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects that posses circulating emboli.		One year