MDA D-Dimer / Recurrent DVT Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2007-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Deep Vein Thrombosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No