CClinicalTrials.gg
CompletedNCT00157599Updated Jul 26, 2011

MDA D-Dimer / Recurrent DVT Study

An interventional study of various diagnostic measures for DVT (e.g., CUS) in Deep Vein Thrombosis, sponsored by McMaster University. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-26.

Sponsored by McMaster University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Deep Vein Thrombosis

Keywords

  • deep vein thrombosis
  • DVT
03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 500 is above the median of 106 across 849 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18 or older
  • Currently suspected for recurrent DVT
  • Has a prior history of objectively documented DVT or PE

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants

Interventions

  • Procedurevarious diagnostic measures for DVT (e.g., CUS)
06

What researchers measure

Primary outcomes

  1. Suspected DVT during follow-up

  2. Suspected PE during follow-up

07

Study locations

6 sites
  • Hamilton General Hospital
    Hamilton, Ontario L8L 2X2, Canada
  • McMaster University Medical Centre
    Hamilton, Ontario L8N 3Z5, Canada
  • St. Joseph's Hospital
    Hamilton, Ontario L8N 4A6, Canada
  • Henderson Research Centre
    Hamilton, Ontario L8V 1C3, Canada
  • Sir Mortimer B. Davis Jewish General
    Montreal, Quebec H3T 1E2, Canada
  • Academic Medical Centre
    Amsterdam, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00157599
Lead sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR)
First posted
Sep 12, 2005
Start date
Jan 2002
Completion
Mar 2007
Last update
Jul 26, 2011

Study contacts

Shannon Bates, M.D.
principal investigator · McMaster University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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