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D-Dimer and IPG for Recurrent Thrombosis (DIRECT)

D-Dimer and IPG for Recurrent Thrombosis (DIRECT) Study

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00182247
Enrollment
600
Registered
2005-09-16
Start date
1998-12-31
Completion date
2001-01-31
Last updated
2005-09-16

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

Conditions

Deep Vein Thrombosis, Pulmonary Embolism

Keywords

deep vein thrombosis, DVT, pulmonary embolism, PE, venous thromboembolism, VTE, d-dimer, IPG

Brief summary

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.

Interventions

PROCEDUREvenogram

Sponsors

Heart and Stroke Foundation of Canada
CollaboratorOTHER
Hamilton Health Sciences Corporation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
symptomatic DVT and PE in follow-up

Secondary

MeasureTime frame
death
deep vein thrombosis diagnosed by venography in those
randomized to that intervention

Countries

Canada, Italy

Outcome results

None listed

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