D-Dimer and IPG for Recurrent Thrombosis (DIRECT)

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-12-31

Study Completion Date

2001-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Deep Vein Thrombosis Pulmonary Embolism

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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venogram

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Shannon Bates, M.D.

Role: STUDY_CHAIR

Hamilton Health Sciences Corporation

Jeffrey Ginsberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Review additional registry numbers or institutional identifiers associated with this trial.

CTMG-1998-DIRECT

Identifier Type: -

Identifier Source: org_study_id

D-Dimer and IPG for Recurrent Thrombosis (DIRECT)

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

venogram

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Heart and Stroke Foundation of Canada

Hamilton Health Sciences Corporation

Principal Investigators

Shannon Bates, M.D.

Jeffrey Ginsberg, M.D.

Locations

Hamilton General Hospital

McMaster University Medical Centre

St. Joseph' Hospital

Henderson General Hospital

Chedoke Hospital

London Health Sciences Centre

CHA - Pavillon Saint-Sacrement

IRCCS Policlinico S. Matteo

Countries

Other Identifiers

CTMG-1998-DIRECT