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MDA D-Dimer / Recurrent DVT Study

A Cohort Study Evaluating the Safety of a Diagnostic Strategy Involving D-Dimer and Compression Ultrasonography in Patients With Suspected Recurrent Deep Vein Thrombosis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00157599
Enrollment
500
Registered
2005-09-12
Start date
2002-01-31
Completion date
2007-03-31
Last updated
2011-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis

Keywords

deep vein thrombosis, DVT

Brief 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.

Interventions

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

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
McMaster University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frame
Suspected DVT during follow-up
Suspected PE during follow-up

Countries

Canada, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026