Back to resultsD-Dimer Vs Serial Compression Ultrasound Study
Primary Purpose
Deep Vein Thrombosis
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
D-dimer
Serial Compression Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Deep Vein Thrombosis focused on measuring deep vein thrombosis, d-dimer, serial compression ultrasound
Eligibility Criteria
Inclusion Criteria: first suspected deep vein thrombosis no previous venous thromboembolism referred to thromboembolism outpatient clinic Exclusion Criteria: comorbid condition limiting survival to less than six months contraindication to venography (contrast allergy, etc.) receiving long term warfarin therapy receiving full dose heparin therapy for more than 48 hours absence of symptoms during the five days immediately prior to presentation symptoms of pulmonary embolism pregnancy geographic inaccessibility which precludes follow-up
Sites / Locations
- Hamilton Health Sciences - Hamilton General Hospital
- St. Joseph's Hospital
- Hamilton Health Sciences - Henderson Hospital
Outcomes
Primary Outcome Measures
safety of withholding anticoagulants
Secondary Outcome Measures
deep vein thrombosis
pulmonary embolism
death
Full Information
NCT ID
NCT00182351
First Posted
September 13, 2005
Last Updated
September 7, 2006
Sponsor
Hamilton Health Sciences Corporation
Collaborators
Health Canada
1. Study Identification
Unique Protocol Identification Number
NCT00182351
Brief Title
D-Dimer Vs Serial Compression Ultrasound Study
Official Title
Evaluation of the Safety, Efficacy and Cost-Effectiveness of Two Strategies for the Diagnosis of Deep Vein Thrombosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
April 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 1999 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
Health Canada
4. Oversight
5. Study Description
Brief Summary
To determine whether d-dimer testing can be used to simplify and reduce the costs of the diagnostic approach to patients with clinically suspected deep vein thrombosis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis
Keywords
deep vein thrombosis, d-dimer, serial compression ultrasound
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
810 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
D-dimer
Intervention Type
Procedure
Intervention Name(s)
Serial Compression Ultrasound
Primary Outcome Measure Information:
Title
safety of withholding anticoagulants
Secondary Outcome Measure Information:
Title
deep vein thrombosis
Title
pulmonary embolism
Title
death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
first suspected deep vein thrombosis
no previous venous thromboembolism
referred to thromboembolism outpatient clinic
Exclusion Criteria:
comorbid condition limiting survival to less than six months
contraindication to venography (contrast allergy, etc.)
receiving long term warfarin therapy
receiving full dose heparin therapy for more than 48 hours
absence of symptoms during the five days immediately prior to presentation
symptoms of pulmonary embolism
pregnancy
geographic inaccessibility which precludes follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clive Kearon, MB
Organizational Affiliation
Hamilton Health Sciences and McMaster University
Official's Role
Study Chair
Facility Information:
Facility Name
Hamilton Health Sciences - Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
St. Joseph's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Hamilton Health Sciences - Henderson Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
15809460
Citation
Kearon C, Ginsberg JS, Douketis J, Crowther MA, Turpie AG, Bates SM, Lee A, Brill-Edwards P, Finch T, Gent M. A randomized trial of diagnostic strategies after normal proximal vein ultrasonography for suspected deep venous thrombosis: D-dimer testing compared with repeated ultrasonography. Ann Intern Med. 2005 Apr 5;142(7):490-6. doi: 10.7326/0003-4819-142-7-200504050-00007.
Results Reference
result
Learn more about this trial
D-Dimer Vs Serial Compression Ultrasound Study
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