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

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

MedlinePlus related topics:

Pulmonary Embolism

U.S. FDA Resources

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

Further study details as provided by Hamilton Health Sciences:

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

Hamilton Health Sciences

Heart and Stroke Foundation of Ontario

Investigators


Principal Investigator:	Lori Linkins, MD	Hamilton Health Sciences

Principal Investigator:	Clive Kearon, MD	Hamilton Health Sciences

Principal Investigator:	Jim Julian, MMath	McMaster University, Dept. of Clinical Epidemiology and Biostatistics

More Information

Responsible Party:	McMaster University ( Lori Linkins, MD )
Study ID Numbers:	CTMG-2005-SELECT, Grant Number: NA 5429
First Received:	September 8, 2005
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00157677
Health Authority:	Canada: Health Canada

Keywords provided by Hamilton Health Sciences:

deep vein thrombosis

pulmonary embolism

D-dimer testing

Study placed in the following topic categories:

Antiplasmin

Embolism and Thrombosis

Pulmonary Embolism

Embolism

Vascular Diseases

Fibrin fragment D

Venous Thrombosis

Thrombosis

Additional relevant MeSH terms:

Fibrin Modulating Agents

Antifibrinolytic Agents

Coagulants

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Hematologic Agents

Cardiovascular Diseases

Hemostatics

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Hamilton Health Sciences Heart and Stroke Foundation of Ontario
Information provided by:	Hamilton Health Sciences
ClinicalTrials.gov Identifier:	NCT00157677