D-Dimer and IPG for Recurrent Thrombosis (DIRECT)
Primary Purpose
Deep Vein Thrombosis, Pulmonary Embolism
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
venogram
Sponsored by
About this trial
This is an interventional diagnostic trial for Deep Vein Thrombosis focused on measuring deep vein thrombosis, DVT, pulmonary embolism, PE, venous thromboembolism, VTE, d-dimer, IPG
Eligibility Criteria
Inclusion Criteria: suspected deep vein thrombosis history of previous DVT or PE Exclusion Criteria: comorbid condition limiting survival to less than 6 months contraindication to contrast medium (allergy, renal dysfunction, creatinine > 150mcmol/L) receiving long-term warfarin or heparin therapy received full-dose heparin therapy for more than 48 hours pregnancy symptomatic for pulmonary embolism absence of symptoms within 5 days of presentation geographic inaccessibility which precludes follow-up
Sites / Locations
- Hamilton General Hospital
- McMaster University Medical Centre
- St. Joseph' Hospital
- Henderson General Hospital
- Chedoke Hospital
- London Health Sciences Centre
- CHA - Pavillon Saint-Sacrement
- IRCCS Policlinico S. Matteo
Outcomes
Primary Outcome Measures
symptomatic DVT and PE in follow-up
Secondary Outcome Measures
death
deep vein thrombosis diagnosed by venography in those
randomized to that intervention
Full Information
NCT ID
NCT00182247
First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
Hamilton Health Sciences Corporation
Collaborators
Heart and Stroke Foundation of Canada
1. Study Identification
Unique Protocol Identification Number
NCT00182247
Brief Title
D-Dimer and IPG for Recurrent Thrombosis (DIRECT)
Official Title
D-Dimer and IPG for Recurrent Thrombosis (DIRECT) Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Terminated
Study Start Date
December 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
Heart and Stroke Foundation of Canada
4. Oversight
5. Study Description
Brief Summary
To simplify and improve the diagnostic approach to patients with clinically suspected recurrent DVT by determining whether the results of the combination of IPG and d-dimer testing, using a whole blood agglutination assay, can be used in the management of such patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Pulmonary Embolism
Keywords
deep vein thrombosis, DVT, pulmonary embolism, PE, venous thromboembolism, VTE, d-dimer, IPG
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
venogram
Primary Outcome Measure Information:
Title
symptomatic DVT and PE in follow-up
Secondary Outcome Measure Information:
Title
death
Title
deep vein thrombosis diagnosed by venography in those
Title
randomized to that intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
suspected deep vein thrombosis
history of previous DVT or PE
Exclusion Criteria:
comorbid condition limiting survival to less than 6 months
contraindication to contrast medium (allergy, renal dysfunction, creatinine > 150mcmol/L)
receiving long-term warfarin or heparin therapy
received full-dose heparin therapy for more than 48 hours
pregnancy
symptomatic for pulmonary embolism
absence of symptoms within 5 days of presentation
geographic inaccessibility which precludes follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Bates, M.D.
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jeffrey Ginsberg, M.D.
Organizational Affiliation
Hamilton Health Sciences Corporation
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' Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Henderson General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Chedoke Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
CHA - Pavillon Saint-Sacrement
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
IRCCS Policlinico S. Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
D-Dimer and IPG for Recurrent Thrombosis (DIRECT)
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