D-Dimer and IPG for Recurrent Thrombosis (DIRECT)

This study has been terminated.

Sponsor:

Collaborator:

Heart and Stroke Foundation of Canada

Information provided by:

McMaster University

ClinicalTrials.gov Identifier:

NCT00182247

First received: September 13, 2005

Last updated: NA

Last verified: September 2005

History: No changes posted

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 13, 2005

Start Date ^ICMJE

December 1998

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

symptomatic DVT and PE in follow-up

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

D-Dimer and IPG for Recurrent Thrombosis (DIRECT)

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Deep Vein Thrombosis
Pulmonary Embolism

Intervention ^ICMJE

Procedure: venogram

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

600

Completion Date

January 2001

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada, Italy

Administrative Information

NCT Number ^ICMJE

NCT00182247

Other Study ID Numbers ^ICMJE

CTMG-1998-DIRECT

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Hamilton Health Sciences Corporation

Collaborators ^ICMJE

Heart and Stroke Foundation of Canada

Investigators ^ICMJE

Study Chair:	Shannon Bates, M.D.	Hamilton Health Sciences Corporation
Principal Investigator:	Jeffrey Ginsberg, M.D.	Hamilton Health Sciences Corporation

Information Provided By

McMaster University

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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