NCT02123550

Brief Summary

This prospective controlled study examines the use of Doppler ultrasound as a means to screen elective plastic surgery patients for the presence of deep venous blood clots both before and after surgery. This is a noninvasive technique that is known to be both sensitive and specific for the detection of deep venous thromboses in the lower extremities. This method may make it unnecessary to select patients for prophylactic anticoagulation, which poses additional risks to the patient.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

8.6 years

First QC Date

April 22, 2014

Last Update Submit

September 6, 2018

Conditions

Deep Venous Thrombosis

Keywords

deepvenousthrombosisDopplerultrasoundplasticsurgerythromboembolismprevention

Outcome Measures

Primary Outcomes (1)

  • Sonographic evidence of a thrombosis

    Doppler ultrasound is used to detect evidence of a deep venous thrombosis.

    1 week

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

2000 study patients consisting of consecutive elective patients undergoing outpatient plastic surgery.

You may qualify if:

  • elective plastic surgery patient
  • consenting patient

You may not qualify if:

  • no consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swanson Center

Leawood, Kansas, 66211, United States

RECRUITING

Related Publications (2)

  • Pannucci CJ, Dreszer G, Wachtman CF, Bailey SH, Portschy PR, Hamill JB, Hume KM, Hoxworth RE, Rubin JP, Kalliainen LK, Pusic AL, Wilkins EG. Postoperative enoxaparin prevents symptomatic venous thromboembolism in high-risk plastic surgery patients. Plast Reconstr Surg. 2011 Nov;128(5):1093-1103. doi: 10.1097/PRS.0b013e31822b6817.

    PMID: 22030491BACKGROUND

  • Swanson E. Prospective Study of Doppler Ultrasound Surveillance for Deep Venous Thromboses in 1000 Plastic Surgery Outpatients. Plast Reconstr Surg. 2020 Jan;145(1):85-96. doi: 10.1097/PRS.0000000000006343.

    PMID: 31881608DERIVED

MeSH Terms

Conditions

Venous ThrombosisThrombosisThromboembolism

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Eric Swanson, M.D.

    Swanson Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Swanson, M.D.

CONTACT

913 663-1030eswanson@swansoncenter.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2014

First Posted

April 25, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

September 10, 2018

Record last verified: 2018-09

Locations

US(1)