The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01300832
First received: February 18, 2011
Last updated: September 4, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Perioperative DVTs
Procedure: Duplex scan of lower extremities

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • The incidence of preoperative DVTs [ Time Frame: Day of surgery ] [ Designated as safety issue: Yes ]
  • Incidence of post-operative DVTs [ Time Frame: Within 48 hours of surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Risk factors associated with the development of perioperative DVTs [ Time Frame: Within 180 days of surgery ] [ Designated as safety issue: Yes ]
  • Distribution and laterality [ Time Frame: Within 180 days of surgery ] [ Designated as safety issue: Yes ]
    Level and laterality of clots that develop and association of these with risk factors

  • Risks associated with perioperative DVTs [ Time Frame: Within 180 days of surgery ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 1000
Study Start Date: February 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Duplex scan
Subjects undergo preoperative and post-operative duplex scanning of the lower extremities
Procedure: Duplex scan of lower extremities
Lower extremities will be duplex scanned pre and post-operatively

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18+ and consentable

Exclusion Criteria:

  • Anticoagulation therapy or known DVT
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01300832

Contacts
Contact: David Glick, MD 773-702-5553 dglick@dacc.uchicago.edu

Locations
United States, Illinois
University of Chicago Hospitals Recruiting
Chicago, Illinois, United States, 60637
Contact: David Glick, MD    773-702-5553    dglick@dacc.uchicago.edu   
Principal Investigator: David Glick, MD         
Principal Investigator: Michael O'Connor, MD         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: David Glick, MD University of Chicago, Dept Anesthesia & Critical Care
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01300832     History of Changes
Other Study ID Numbers: 10-589-A
Study First Received: February 18, 2011
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Surgery
Deep Vein Thrombosis
Preoperative

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism

ClinicalTrials.gov processed this record on October 01, 2014