D-Dimer and IPG for Recurrent Thrombosis (DIRECT)

This study has been terminated.

First Received: September 13, 2005 No Changes Posted

Sponsors and Collaborators:	Hamilton Health Sciences Heart and Stroke Foundation of Ontario
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00182247

Purpose

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.

Condition	Intervention	Phase
Deep Vein Thrombosis Pulmonary Embolism	Procedure: venogram	Phase III

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	D-Dimer and IPG for Recurrent Thrombosis (DIRECT) Study

Resource links provided by NLM:

MedlinePlus related topics: Deep Vein Thrombosis Pulmonary Embolism

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:

symptomatic DVT and PE in follow-up

Secondary Outcome Measures:

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

Estimated Enrollment:	600
Study Start Date:	December 1998
Estimated Study Completion Date:	January 2001

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182247

Locations

Canada
CHA - Pavillon Saint-Sacrement
Quebec, Canada, G1S 4L8
Canada, Ontario
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Henderson General Hospital
Hamilton, Ontario, Canada, L8V 1C3
St. Joseph' Hospital
Hamilton, Ontario, Canada, L8N 4A6
Chedoke Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Italy
IRCCS Policlinico S. Matteo
Pavia, Italy, 27100

Sponsors and Collaborators

Hamilton Health Sciences

Heart and Stroke Foundation of Ontario

Investigators

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

More Information

No publications provided

Study ID Numbers:	CTMG-1998-DIRECT
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00182247 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by McMaster University:

deep vein thrombosis
DVT
pulmonary embolism
PE

venous thromboembolism
VTE
d-dimer
IPG

Study placed in the following topic categories:

Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism
Lung Diseases
Vascular Diseases

Fibrin fragment D
Venous Thrombosis
Venous Thromboembolism
Recurrence
Thromboembolism
Thrombosis

Additional relevant MeSH terms:

Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism
Lung Diseases

Vascular Diseases
Cardiovascular Diseases
Venous Thrombosis
Thrombosis

ClinicalTrials.gov processed this record on September 10, 2009