Back to resultsMDA D-Dimer / Recurrent DVT Study
Primary Purpose
Deep Vein Thrombosis
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
various diagnostic measures for DVT (e.g., CUS)
Sponsored by
About this trial
This is an interventional diagnostic trial for Deep Vein Thrombosis focused on measuring deep vein thrombosis, DVT
Eligibility Criteria
Inclusion Criteria: Age 18 or older Currently suspected for recurrent DVT Has a prior history of objectively documented DVT or PE Exclusion Criteria: Comorbid condition limiting survival to less than 3 months History of hypersensitivity to contrast medium Renal dysfunction with a creatinine of > 150 mcmol/L Treatment with full-dose therapeutic unfractionated or low molecular weight heparin that was initiated 24 hours or more prior to eligibility assessment Pregnancy or lactation Symptomatic for pulmonary embolism Absence of symptoms within five days prior to presentation Participation in another trial precluding the use of the diagnostic algorithm in this study Geographically inaccessible for follow-up Compression ultrasound, venogram, IPG, or D-dimer performed PRIOR to assessment
Sites / Locations
- Hamilton General Hospital
- McMaster University Medical Centre
- St. Joseph's Hospital
- Henderson Research Centre
- Sir Mortimer B. Davis Jewish General
- Academic Medical Centre
Outcomes
Primary Outcome Measures
Suspected DVT during follow-up
Suspected PE during follow-up
Secondary Outcome Measures
Full Information
NCT ID
NCT00157599
First Posted
September 7, 2005
Last Updated
July 25, 2011
Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT00157599
Brief Title
MDA D-Dimer / Recurrent DVT Study
Official Title
A Cohort Study Evaluating the Safety of a Diagnostic Strategy Involving D-Dimer and Compression Ultrasonography in Patients With Suspected Recurrent Deep Vein Thrombosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
5. Study Description
Brief Summary
To determine whether treatment and further investigation can be safely withheld in patients who present with suspected recurrent deep vein thrombosis (DVT) and have either a (i) negative D-Dimer or (ii) a positive D-Dimer with normal serial compression ultrasound.
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, DVT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
various diagnostic measures for DVT (e.g., CUS)
Primary Outcome Measure Information:
Title
Suspected DVT during follow-up
Title
Suspected PE during follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or older
Currently suspected for recurrent DVT
Has a prior history of objectively documented DVT or PE
Exclusion Criteria:
Comorbid condition limiting survival to less than 3 months
History of hypersensitivity to contrast medium
Renal dysfunction with a creatinine of > 150 mcmol/L
Treatment with full-dose therapeutic unfractionated or low molecular weight heparin that was initiated 24 hours or more prior to eligibility assessment
Pregnancy or lactation
Symptomatic for pulmonary embolism
Absence of symptoms within five days prior to presentation
Participation in another trial precluding the use of the diagnostic algorithm in this study
Geographically inaccessible for follow-up
Compression ultrasound, venogram, IPG, or D-dimer performed PRIOR to assessment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Bates, M.D.
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
St. Joseph's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Henderson Research Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Sir Mortimer B. Davis Jewish General
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Academic Medical Centre
City
Amsterdam
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
MDA D-Dimer / Recurrent DVT Study
We'll reach out to this number within 24 hrs