MDA D-Dimer / Recurrent DVT Study

Deep Vein Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157599
• Other study ID #: CTMG-2002-MDA
• Status: Completed
• Phase: N/A
• First received: September 7, 2005
• Last updated: July 25, 2011
• Start date: January 2002
• Est. completion date: March 2007

Study information

• Verified date: October 2007
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Procedure:
• various diagnostic measures for DVT (e.g., CUS)

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Henderson Research Centre	Hamilton	Ontario
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	St. Joseph's Hospital	Hamilton	Ontario
Canada	Sir Mortimer B. Davis Jewish General	Montreal	Quebec
Netherlands	Academic Medical Centre	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

Canada,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suspected DVT during follow-up
Primary	Suspected PE during follow-up