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.

Condition	Intervention
Deep Vein Thrombosis	Procedure: various diagnostic measures for DVT (e.g., CUS)

Further Study Details: 

Primary Outcomes: Suspected DVT during follow-up; Suspected PE during follow-up
Expected Total Enrollment:  500

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00157599

Lorraine Weise-Kelly, Ph.D.      905-527-2299  Ext. 43772    kellyla@mcmaster.ca
Mike Wild      905-527-2299  Ext. 42634    mwild@mcmaster.ca

Canada, Ontario
      Henderson Research Centre, Hamilton,  Ontario,  L8V 1C3,  Canada; Recruiting
      McMaster University Medical Centre, Hamilton,  Ontario,  L8N 3Z5,  Canada; Recruiting
      Hamilton General Hospital, Hamilton,  Ontario,  L8L 2X2,  Canada; No longer recruiting
      St. Joseph''''s Hospital, Hamilton,  Ontario,  L8N 4A6,  Canada; Recruiting
Canada, Quebec
      Sir Mortimer B. Davis Jewish General, Montreal,  Quebec,  H3T 1E2,  Canada; Recruiting
Netherlands
      Academic Medical Centre, Amsterdam,  Netherlands; Recruiting

Study chairs or principal investigators

Shannon Bates, M.D.,  Principal Investigator,  McMaster University   

Study ID Numbers:  CTMG-2002-MDA
Last Updated:  September 10, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00157599
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-13