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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
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Outcomes
Full info

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

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
Hamilton Health Sciences Corporation
Collaborators
Heart and Stroke Foundation of Canada
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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

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D-Dimer and IPG for Recurrent Thrombosis (DIRECT)

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