D-Dimer and IPG for Recurrent Thrombosis (DIRECT)

Hamilton Health Sciences (HHS)

Status and phase: Terminated; Phase 3

Conditions: Pulmonary Embolism; Deep Vein Thrombosis

Treatments: Procedure: venogram

Study type: Interventional

Funder types: Other

Identifiers

NCT00182247

CTMG-1998-DIRECT

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)