Back to resultsThe Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities
Primary Purpose
Perioperative DVTs
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Duplex scan of lower extremities
Sponsored by
About this trial
This is an interventional screening trial for Perioperative DVTs focused on measuring Surgery, Deep Vein Thrombosis, Preoperative
Eligibility Criteria
Inclusion Criteria:
- Age 18+ and consentable
Exclusion Criteria:
- Anticoagulation therapy or known DVT
Sites / Locations
- University of Chicago Hospitals
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Duplex scan
Arm Description
Subjects undergo preoperative and post-operative duplex scanning of the lower extremities
Outcomes
Primary Outcome Measures
The incidence of preoperative DVTs
Incidence of post-operative DVTs
Secondary Outcome Measures
Risk factors associated with the development of perioperative DVTs
Distribution and laterality
Level and laterality of clots that develop and association of these with risk factors
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01300832
Brief Title
The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities
Official Title
The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2011 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative DVTs
Keywords
Surgery, Deep Vein Thrombosis, Preoperative
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
271 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Duplex scan
Arm Type
Experimental
Arm Description
Subjects undergo preoperative and post-operative duplex scanning of the lower extremities
Intervention Type
Procedure
Intervention Name(s)
Duplex scan of lower extremities
Intervention Description
Lower extremities will be duplex scanned pre and post-operatively
Primary Outcome Measure Information:
Title
The incidence of preoperative DVTs
Time Frame
Day of surgery
Title
Incidence of post-operative DVTs
Time Frame
Within 48 hours of surgery
Secondary Outcome Measure Information:
Title
Risk factors associated with the development of perioperative DVTs
Time Frame
Within 180 days of surgery
Title
Distribution and laterality
Description
Level and laterality of clots that develop and association of these with risk factors
Time Frame
Within 180 days of surgery
Title
Risks associated with perioperative DVTs
Description
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
Time Frame
Within 180 days of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18+ and consentable
Exclusion Criteria:
Anticoagulation therapy or known DVT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Glick, MD
Organizational Affiliation
University of Chicago, Dept Anesthesia & Critical Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Hospitals
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities
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