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OpenTrials
Completed

NCT Number: NCT00157599

MDA D-Dimer / Recurrent DVT Study

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.

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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton General Hospital, Hamilton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

Primary outcomes

  1. Suspected DVT during follow-up

  2. Suspected PE during follow-up

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Jul 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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