The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities

Perioperative DVTs Clinical Trial

Official title:

The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300832
• Other study ID #: 10-589-A
• Status: Completed
• Phase: N/A
• Start date: February 1, 2011
• Est. completion date: December 1, 2022

Study information

• Verified date: June 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18+ and consentable

Exclusion Criteria:

• Anticoagulation therapy or known DVT

Related Conditions & MeSH terms

• Perioperative DVTs
• Thrombosis
• Venous Thrombosis

Intervention

Procedure:
• Duplex scan of lower extremities
Lower extremities will be duplex scanned pre and post-operatively

Locations

Country	Name	City	State
United States	University of Chicago Hospitals	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of preoperative DVTs		Day of surgery
Primary	Incidence of post-operative DVTs		Within 48 hours of surgery
Secondary	Risk factors associated with the development of perioperative DVTs		Within 180 days of surgery
Secondary	Distribution and laterality	Level and laterality of clots that develop and association of these with risk factors	Within 180 days of surgery
Secondary	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	Within 180 days of surgery