Detecting Circulating Emboli in Patients with Acute Venous Thromboembolism

NCT02735759 | Withdrawn FDA Device

• 1 other identifier: 205341.
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

• Number of subjects that posses circulating emboli.

  One year

Study Arms (2)

Healthy Volunteers

OTHER

This cohort will consist of ten healthy volunteers. The photoacoustic flow cytometry device will be used to establish device settings. The intervention with the subject will include the PAFC device to establish appropriate device settings.

Device: Photoacoustic flow cytometry device

Venous Thromboembolism

OTHER

This cohort will consist of ten patients with newly diagnosed, non-life threatening acute venous thromboembolism. The intervention with the subjects is to perform the photoacoustic flow cytometry device to detect circulating emboli in vivo in patients with venous thromboembolism at diagnosis, during and after anticoagulation therapy.

Device: Photoacoustic flow cytometry device

Interventions

Photoacoustic flow cytometry device 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.

Healthy Volunteers; Venous Thromboembolism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and older
• Willing to adhere to protocol.
• Signed informed consent

You may not qualify if:

• Unable to provide informed consent.
• History of venous thromboembolism.
• Currently receiving anticoagulant therapy.
• 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.
• Life threatening venous thromboembolism.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zhifu Xiang, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: April 13, 2016
• Study Start: July 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 3, 2024

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)