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

Sponsor:	McMaster University
Collaborator:	Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic
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 ]

Enrollment:	1727
Study Start Date:	October 2004
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

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

Locations

Canada, Ontario
Hamilton Health Sciences, Henderson
Hamilton, Ontario, Canada, L8V 1C3
Hamilton Health Sciences, McMaster
Hamilton, Ontario, Canada, L8N 3Z5
Hamilton Health Sciences, General
Hamilton, Ontario, Canada
St. Joseph's Health Care Centre
Hamilton, Ontario, Canada, L8N 4A6
Canada, Quebec
SMBD Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2

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
ClinicalTrials.gov Identifier:	NCT00157677 History of Changes
Other Study ID Numbers:	CTMG-2005-SELECT, Grant Number: NA 5429
Study First Received:	September 8, 2005
Last Updated:	October 25, 2011
Health Authority:	Canada: Health Canada

Keywords provided by McMaster University:

deep vein thrombosis
pulmonary embolism
D-dimer testing

Additional relevant MeSH terms:

Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrin fragment D
Antifibrinolytic Agents

Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 13, 2012