D-Dimer and IPG for Recurrent Thrombosis (DIRECT) Study

D-Dimer and IPG for Recurrent Thrombosis (DIRECT)

Sponsors

Lead sponsor: Hamilton Health Sciences Corporation

Collaborator: Heart and Stroke Foundation of Canada

Source McMaster University
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.

Overall Status Terminated
Start Date December 1998
Completion Date January 2001
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
symptomatic DVT and PE in follow-up
Secondary Outcome
Measure Time Frame
death
deep vein thrombosis diagnosed by venography in those
randomized to that intervention
Enrollment 600
Condition
Intervention

Intervention type: Procedure

Intervention name: venogram

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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Location
facility
Hamilton General Hospital | Hamilton, Ontario, L8L 2X2, Canada
McMaster University Medical Centre | Hamilton, Ontario, L8N 3Z5, Canada
St. Joseph' Hospital | Hamilton, Ontario, L8N 4A6, Canada
Henderson General Hospital | Hamilton, Ontario, L8V 1C3, Canada
Chedoke Hospital | Hamilton, Ontario, Canada
London Health Sciences Centre | London, Ontario, N6A 4G5, Canada
CHA - Pavillon Saint-Sacrement | Quebec, G1S 4L8, Canada
IRCCS Policlinico S. Matteo | Pavia, 27100, Italy
Location Countries

Canada

Italy

Verification Date

September 2005

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov