D-Dimer and IPG for Recurrent Thrombosis (DIRECT)

Phase 3TerminatedNCT00182247

Hamilton Health Sciences Corporation600 enrolled

Overview

To simplify and improve the diagnostic approach to patients with clinically suspected recurrent DVT by determining whether the results of the combination of IPG and d-dimer testing, using a whole blood agglutination assay, can be used in the management of such patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

600

Conditions

Deep Vein Thrombosis Pulmonary Embolism

Interventions

venogramPROCEDURE

Eligibility

Sex: ALLMin age: 0 Years

Medical Language ↔ Plain English

Inclusion Criteria: * suspected deep vein thrombosis * history of previous DVT or PE Exclusion Criteria: * comorbid condition limiting survival to less than 6 months * contraindication to contrast medium (allergy, renal dysfunction, creatinine \> 150mcmol/L) * receiving long-term warfarin or heparin therapy * received full-dose heparin therapy for more than 48 hours * pregnancy * symptomatic for pulmonary embolism * absence of symptoms within 5 days of presentation * geographic inaccessibility which precludes follow-up

Locations (8)

Hamilton General Hospital

Hamilton, Ontario, Canada

McMaster University Medical Centre

Hamilton, Ontario, Canada

St. Joseph' Hospital

Hamilton, Ontario, Canada

Henderson General Hospital

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

symptomatic DVT and PE in follow-up

Secondary Outcomes

death

deep vein thrombosis diagnosed by venography in those

randomized to that intervention

Data from ClinicalTrials.gov

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