Perioperative DVTsNCT01300832
The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities
A study testing Duplex scan of lower extremities in people with Perioperative DVTs, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The study's hypothesis is that there are some patients who come for surgery who have asymptomatic clots in their lower extremities upon their arrival to the hospital for their surgical admission. We will be performing duplex studies of the subjects' legs before their surgery to determine how often clots are present. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative DVTs
- What is being tested?
- Duplex scan of lower extremities
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2011to 1 Dec 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+ and consentable
Who cannot join
- Anticoagulation therapy or known DVT
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Hospitals
Chicago, Illinois, 60637
About this study
The study's hypothesis is that there are some patients who come for surgery who have asymptomatic clots in their lower extremities upon their arrival to the hospital for their surgical admission. We will be performing duplex studies of the subjects' legs before their surgery to determine how often clots are present. We will also perform duplex scans of the legs after the subjects' surgeries to determine what factors (surgical, anesthetic, co-morbidities)are correlated with the development of DVTs.
- Conditions
- Perioperative DVTs
- Being tested
- Duplex scan of lower extremities
- Keywords
- Surgery, Deep Vein Thrombosis, Preoperative
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duplex scan of lower extremitiesProcedure or surgery
Lower extremities will be duplex scanned pre and post-operatively
| Study group | Role | What they receive |
|---|---|---|
| Duplex scan | Experimental | Subjects undergo preoperative and post-operative duplex scanning of the lower extremities Receives: Procedure: Duplex scan of lower extremities |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of preoperative DVTs
Measured: Day of surgery
Incidence of post-operative DVTs
Measured: Within 48 hours of surgery
Secondary outcomes (3)
Risk factors associated with the development of perioperative DVTs
Measured: Within 180 days of surgery
Distribution and laterality
Level and laterality of clots that develop and association of these with risk factors
Measured: Within 180 days of surgery
Risks associated with perioperative DVTs
Association of clinical pulmonary emboli and/or cardiac arrests, cerebral vascular events, or other causes of death or significant morbidities (e.g., post-op pneumonias or other infections)perioperatively with DVTs
Measured: Within 180 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study start1 Feb 2011
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative DVTsStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Glick, MD, Principal investigator, University of Illinois at Chicago, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300832
- Sponsor's protocol ID
- 10-589-A
- Status last verified
- Jul 2024
- First submitted
- 18 Feb 2011
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities
- ClinicalTrials.gov ID
- NCT01300832
- Acronym / sponsor ID
- 10-589-A
- Conditions
- Perioperative DVTs
- Keywords
- Surgery, Deep Vein Thrombosis, Preoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Feb 2011 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 23 Feb 2011 (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.
The study's hypothesis is that there are some patients who come for surgery who have asymptomatic clots in their lower extremities upon their arrival to the hospital for their surgical admission. We will be performing duplex studies of the subjects' legs before their surgery to determine how often clots are present. We will also perform duplex scans of the legs after the subjects' surgeries to determine what factors (surgical, anesthetic, co-morbidities)are correlated with the development of DVTs.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duplex scan | Experimental | Procedure: Duplex scan of lower extremitiesSubjects undergo preoperative and post-operative duplex scanning of the lower extremities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18+ and consentable
Key exclusion criteria (1 listed)
- Anticoagulation therapy or known DVT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duplex scan of lower extremitiesLower extremities will be duplex scanned pre and post-operatively | Procedure or surgery | Duplex scan |
Primary outcome
The incidence of preoperative DVTs
Time frame: Day of surgery
Incidence of post-operative DVTs
Time frame: Within 48 hours of surgery
3 secondary outcomes
Risk factors associated with the development of perioperative DVTs
Time frame: Within 180 days of surgery
Distribution and laterality
Time frame: Within 180 days of surgery
Risks associated with perioperative DVTs
Time frame: Within 180 days of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
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.
David Glick, MD principal investigator
University of Illinois at Chicago, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duplex scan of lower extremities in people with Perioperative DVTs, run by University of Illinois Chicago 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 1 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: finished, as of the sponsor's last update on 23 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of preoperative DVTs (time frame: Day of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2024.