D-Dimer and IPG for Recurrent Thrombosis (DIRECT)

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00182247
• Other study ID #: CTMG-1998-DIRECT
• Status: Terminated
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 13, 2005
• Start date: December 1998
• Est. completion date: January 2001

Study information

• Verified date: September 2005
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 600
• Est. completion date: January 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Procedure:
• venogram

Locations

Country	Name	City	State
Canada	Chedoke Hospital	Hamilton	Ontario
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Henderson General Hospital	Hamilton	Ontario
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	St. Joseph' Hospital	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	CHA - Pavillon Saint-Sacrement	Quebec
Italy	IRCCS Policlinico S. Matteo	Pavia

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Heart and Stroke Foundation of Canada

Countries where clinical trial is conducted

Canada,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptomatic DVT and PE in follow-up
Secondary	death
Secondary	deep vein thrombosis diagnosed by venography in those
Secondary	randomized to that intervention