Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis (SELECT) - Full Text View

Sponsors and Collaborators:	McMaster University Heart and Stroke Foundation of Ontario
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00157677

Purpose

The purpose of this study is to compare two diagnostic interventions to improve the way D-dimer blood testing (MDA D-dimer) is used to diagnose first time symptomatic deep vein thrombosis.

Condition	Intervention	Phase
Deep Vein Thrombosis	Procedure: D-dimer testing	Phase III

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis: A Randomized Trial

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:

objectively confirmed proximal deep vein thrombosis or pulmonary embolism during 3 months of follow-up in patients who are not diagnosed with deep vein thrombosis during diagnostic testing and are not anticoagulated [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

bleeding [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
healthcare utilization [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
cost-effectiveness [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	2000
Study Start Date:	October 2004
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Selective D-Dimer use	Procedure: D-dimer testing Selective D-Dimer use
2: Active Comparator Uniform D-Dimer use	Procedure: D-dimer testing Uniform D-dimer use

Detailed Description:

Limiting use of D-dimer testing to outpatients with a Low or Moderate clinical pretest probability (C-PTP)for deep vein thrombosis AND using a D-dimer level of < 1.0 µg FEU/mL to exclude deep vein thrombosis in those with a Low C-PTP, and a D-dimer level of < 0.5 µg FEU/mL to exclude deep vein thrombosis in those with a

Moderate C-PTP, is as safe and a more efficient way to diagnose DVT than:

Performing D-dimer testing in all patients with suspected deep vein thrombosis with use of a single D-dimer value of < 0.5 µg FEU/mL to exclude thrombosis (current practice).

All randomized patients, including those who are treated for deep vein thrombosis after initial testing, will be followed for a period of 3 months to monitor for signs and symptoms suggestive of deep vein thrombosis, pulmonary embolism, bleeds and death.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18 and older
Presenting with symptoms compatible with clinically suspected deep vein thrombosis

Exclusion Criteria:

Treatment with full dose anticoagulation for 24 hours or more.
Other test for deep vein thrombosis already performed.
Ongoing need for therapeutic anticoagulant therapy.
Life expectancy less than 3 months.
Absence of acute symptoms within 7 days of presentation.
Presenting with symptoms of pulmonary embolism.
Previous confirmed episode of deep vein thrombosis or pulmonary embolism.
Current pregnancy.
Geographic inaccessibility which precludes follow-up.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157677

Contacts

Contact: Clare Stewart, MA	905-527-2299 ext 43791	stewartc@mcmaster.ca
Contact: Rosemarie Miksza-Todd	905-527-2299 ext 43798	mikszat@mcmaster.ca

Locations

Canada, Ontario
Hamilton Health Sciences, Henderson	Recruiting
Hamilton, Ontario, Canada, L8V 1C3
Contact: Lori Linkins, MD 905-527-4322 ext 43759 LLinkins@thrombosis.hhscr.org
Contact: Clive Kearon, MD 905-383-2251 kearonc@mcmaster.ca
Principal Investigator: Lori Linkins, MD
Hamilton Health Sciences, McMaster	Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Shannon Bates, MD 905-521-2100 ext 73928
Contact: Jeff Ginsberg, MD 905-521-2100 ext 76973 ginsbrgi@mcmaster.ca
Principal Investigator: Shannon Bates, MD
Hamilton Health Sciences, General	Recruiting
Hamilton, Ontario, Canada
Contact: Sam Schulman, MD
Principal Investigator: Sam Schulman, MD
St. Joseph's Health Care Centre	Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: James Douketis, MD 905-521-6178 jdouket@mcmaster.ca
Principal Investigator: James Douketis, MD
Canada, Quebec
SMBD Jewish General Hospital	Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Eddy Lang, MD 514-340-8222 ext 3447 eddy.lang@mcgill.ca
Contact: Susan Kahn, MD 514-340-8222 ext 4667 susan.kahn@mcgill.ca
Principal Investigator: Eddy Lang, MD

Sponsors and Collaborators

McMaster University

Heart and Stroke Foundation of Ontario

Investigators

Principal Investigator:	Lori Linkins, MD	McMaster University
Principal Investigator:	Clive Kearon, MD	McMaster University
Principal Investigator:	Jim Julian, MMath	McMaster University, Dept. of Clinical Epidemiology and Biostatistics

More Information

No publications provided

Responsible Party:	McMaster University ( Lori Linkins, MD )
Study ID Numbers:	CTMG-2005-SELECT, Grant Number: NA 5429
Study First Received:	September 8, 2005
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00157677 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by McMaster University:

deep vein thrombosis
pulmonary embolism
D-dimer testing

Study placed in the following topic categories:

Fibrin Modulating Agents
Antiplasmin
Embolism and Thrombosis
Antifibrinolytic Agents
Pulmonary Embolism
Embolism

Vascular Diseases
Fibrin fragment D
Venous Thrombosis
Hemostatics
Thrombosis

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Coagulants
Hematologic Agents
Vascular Diseases
Fibrin fragment D
Thrombosis
Pharmacologic Actions

Hemostatics
Embolism and Thrombosis
Fibrin Modulating Agents
Antifibrinolytic Agents
Therapeutic Uses
Venous Thrombosis
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 11, 2009