Deep Venous ThrombosisNCT02123550
Doppler Ultrasound Imaging of Plastic Surgery Patients for DVT Detection
An observational study of Deep Venous Thrombosis, run by Swanson Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deep Venous Thrombosis
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 2000 study patients consisting of consecutive elective patients undergoing outpatient plastic surgery.
Who may be able to join
- elective plastic surgery patient
- consenting patient
Who cannot join
- no consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Swanson Center
Leawood, Kansas, 66211
Eric Swanson, M.D., 913-663-1030, eswanson@swansoncenter.com
Eric Swanson, M.D.
About this study
Official title: Doppler Ultrasound Imaging of Plastic Surgery Patients for Deep Venous Thrombosis Detection: A Prospective Controlled Study.
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.
Read the detailed description
Protocol
Investigation of Deep Venous Thromboses in Elective Cosmetic Surgery Patients using Doppler Ultrasound
Background/Purpose
Venous thromboembolism is a well-known and serious risk of surgery. In an attempt to reduce the frequency of this postoperative complication, many plastic surgeons today elect to anticoagulate patients deemed to be at higher risk.1 The efficacy and ethics of this treatment have been challenged.2 Moreover, prophylactic anticoagulation poses additional serious risks of its own, including increased bleeding and wound hematomas.2 It makes sense to use a screening device to detect not just symptomatic cases but also subclinical deep venous thrombosis so that treatment can be promptly initiated and patients without evidence of blood clots can be spared the needless side effects of anticoagulation.
Doppler ultrasound imaging represents a sensitive, direct, and noninvasive method to screen for the presence of venous thromboses.3 This prospective study is undertaken to determine its feasibility in the setting of outpatient plastic surgery. Doppler ultrasound imaging as a screening tool for elective plastic surgery patients has not been previously published. This test is added to the perioperative protocol, which is otherwise unchanged.
Subjects
Two hundred consecutive consenting adult men and women undergoing outpatient elective plastic surgery under total intravenous anesthesia will be investigated using Doppler ultrasound scans preoperatively, on the first day after surgery, and approximately 1 week after surgery. Common operations included liposuction, abdominoplasty, facelifts, and cosmetic breast surgery. In addition, 25 control patients (i.e., men and women not having surgery) will be investigated at the same intervals.
Scans
The Terason t3200 Ultrasound System Vascular series images the deep veins of both lower extremities. The veins evaluated with this imaging technique consist of the common femoral, greater saphenous, superficial femoral, popliteal, and posterior tibial veins. Both color Doppler flow and 2-dimensional compression tests (Duplex scans) are performed. The thickness of the adipose layer is also measured and patient weights are recorded to check for any possible correlations.
Clinical measures to reduce the risk of venous thrombosis include: (1) spontaneous breathing without muscle relaxants, (2) no prone positioning in surgery, (4) sequential compression devices, (4) movement of the lower extremities during surgery, and (5) outpatient treatment with early ambulation.2
Patients are cautioned that deep venous thrombosis (blood clots) are a known risk of surgery and that they are to report any asymmetrical swelling of the lower extremities, thigh pain, or fever to their surgeon immediately. Any patient with a positive scan is referred to a local hospital for confirmation and treatment.
Null Hypothesis
Ultrasound scans are a safe, noninvasive, effective method to detect blood clots in the deep veins of the lower extremities in plastic surgical patients.
Informed Consent
Patients are informed as to the nature of the study and are told that their participation is entirely voluntary and they are free to decline, and that doing so does not in any way prejudice their treatment.
Patient Risk
There is no patient risk. The study does not affect patient treatment. It offers the possibility of detection of sub-clinical deep venous thrombosis.
Sample Size
A sample of 2000 treated patients and 25 controls is anticipated.
Disclosure
The author has no financial interest in any of the products, devices, or drugs mentioned in this article. The author has no conflicts of interest to disclose. There was no outside funding for this study.
- Conditions
- Deep Venous Thrombosis
- Keywords
- deep, venous, thrombosis, Doppler, ultrasound, plastic, surgery, thromboembolism, prevention
- Medical subject headings
- Venous Thrombosis, Thrombosis, Thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Sonographic evidence of a thrombosis
Doppler ultrasound is used to detect evidence of a deep venous thrombosis.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Deep Venous ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swanson Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Swanson, M.D., Principal investigator, Swanson Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123550
- Sponsor's protocol ID
- Swanson01
- Status last verified
- Sep 2018
- First submitted
- 22 Apr 2014
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
1. Pannucci CJ, Dreszer G, Fisher Wachtman C, et al. Postoperative enoxaparin prevents symptomatic venous thromboembolism in high-risk plastic surgery patients. Plast Reconstr Surg. 2011;128:1093-1103. 2. Swanson E. Chemoprophylaxis for venous thromboembolism prevention: Concerns regarding efficacy and ethics. Plast Reconstr Surg. - Global Open. 2013;1:e23. doi: 10.1097/GOX.0b013e318299fa26. 3. Zierler BK. Diagnosis of venous thromboembolism. Circulation 2004;109:I-9-I-14.
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.
PubMed 31881608
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doppler Ultrasound Imaging of Plastic Surgery Patients for Deep Venous Thrombosis Detection: A Prospective Controlled Study.
- ClinicalTrials.gov ID
- NCT02123550
- Acronym / sponsor ID
- Swanson01
- Conditions
- Deep Venous Thrombosis
- Keywords
- deep, venous, thrombosis, Doppler, ultrasound, plastic, surgery, thromboembolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Swanson CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Protocol
Investigation of Deep Venous Thromboses in Elective Cosmetic Surgery Patients using Doppler Ultrasound
Background/Purpose
Venous thromboembolism is a well-known and serious risk of surgery. In an attempt to reduce the frequency of this postoperative complication, many plastic surgeons today elect to anticoagulate patients deemed to be at higher risk.1 The efficacy and ethics of this treatment have been challenged.2 Moreover, prophylactic anticoagulation poses additional serious risks of its own, including increased bleeding and wound hematomas.2 It makes sense to use a screening device to detect not just symptomatic cases but also subclinical deep venous thrombosis so that treatment can be promptly initiated and patients without evidence of blood clots can be spared the needless side effects of anticoagulation.
Doppler ultrasound imaging represents a sensitive, direct, and noninvasive method to screen for the presence of venous thromboses.3 This prospective study is undertaken to determine its feasibility in the setting of outpatient plastic surgery. Doppler ultrasound imaging as a screening tool for elective plastic surgery patients has not been previously published. This test is added to the perioperative protocol, which is otherwise unchanged.
Subjects
Two hundred consecutive consenting adult men and women undergoing outpatient elective plastic surgery under total intravenous anesthesia will be investigated using Doppler ultrasound scans preoperatively, on the first day after surgery, and approximately 1 week after surgery. Common operations included liposuction, abdominoplasty, facelifts, and cosmetic breast surgery. In addition, 25 control patients (i.e., men and women not having surgery) will be investigated at the same intervals.
Scans
The Terason t3200 Ultrasound System Vascular series images the deep veins of both lower extremities. The veins evaluated with this imaging technique consist of the common femoral, greater saphenous, superficial femoral, popliteal, and posterior tibial veins. Both color Doppler flow and 2-dimensional compression tests (Duplex scans) are performed. The thickness of the adipose layer is also measured and patient weights are recorded to check for any possible correlations.
Clinical measures to reduce the risk of venous thrombosis include: (1) spontaneous breathing without muscle relaxants, (2) no prone positioning in surgery, (4) sequential compression devices, (4) movement of the lower extremities during surgery, and (5) outpatient treatment with early ambulation.2
Patients are cautioned that deep venous thrombosis (blood clots) are a known risk of surgery and that they are to report any asymmetrical swelling of the lower extremities, thigh pain, or fever to their surgeon immediately. Any patient with a positive scan is referred to a local hospital for confirmation and treatment.
Null Hypothesis
Ultrasound scans are a safe, noninvasive, effective method to detect blood clots in the deep veins of the lower extremities in plastic surgical patients.
Informed Consent
Patients are informed as to the nature of the study and are told that their participation is entirely voluntary and they are free to decline, and that doing so does not in any way prejudice their treatment.
Patient Risk
There is no patient risk. The study does not affect patient treatment. It offers the possibility of detection of sub-clinical deep venous thrombosis.
Sample Size
A sample of 2000 treated patients and 25 controls is anticipated.
Disclosure
The author has no financial interest in any of the products, devices, or drugs mentioned in this article. The author has no conflicts of interest to disclose. There was no outside funding for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 2000 study patients consisting of consecutive elective patients undergoing outpatient plastic surgery.
Key inclusion criteria (2 listed)
- elective plastic surgery patient
- consenting patient
Key exclusion criteria (1 listed)
- no consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sonographic evidence of a thrombosis
Time frame: 1 week
Doppler ultrasound is used to detect evidence of a deep venous thrombosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Background1. Pannucci CJ, Dreszer G, Fisher Wachtman C, et al. Postoperative enoxaparin prevents symptomatic venous thromboembolism in high-risk plastic surgery patients. Plast Reconstr Surg. 2011;128:1093-1103. 2. Swanson E. Chemoprophylaxis for venous thromboembolism prevention: Concerns regarding efficacy and ethics. Plast Reconstr Surg. - Global Open. 2013;1:e23. doi: 10.1097/GOX.0b013e318299fa26. 3. Zierler BK. Diagnosis of venous thromboembolism. Circulation 2004;109:I-9-I-14.
- Derived from this study: PubMed 31881608Swanson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Swanson, M.D. principal investigator
Swanson Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Venous Thrombosis, run by Swanson Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Swanson, M.D. (913 663-1030, eswanson@swansoncenter.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sonographic evidence of a thrombosis (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02123550, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.