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

NCT ID: NCT00157677

Last Updated: 2011-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1727 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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* 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.

Conditions

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Deep Vein Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Selective D-Dimer use

Group Type EXPERIMENTAL

D-dimer testing

Intervention Type PROCEDURE

Selective D-Dimer use

2

Uniform D-Dimer use

Group Type ACTIVE_COMPARATOR

D-dimer testing

Intervention Type PROCEDURE

Uniform D-dimer use

Interventions

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D-dimer testing

Uniform D-dimer use

Intervention Type PROCEDURE

D-dimer testing

Selective D-Dimer use

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Stroke Foundation of Ontario

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lori Linkins, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Clive Kearon, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Jim Julian, MMath

Role: PRINCIPAL_INVESTIGATOR

McMaster University, Dept. of Clinical Epidemiology and Biostatistics

Locations

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Hamilton Health Sciences, McMaster

Hamilton, Ontario, Canada

Site Status

St. Joseph's Health Care Centre

Hamilton, Ontario, Canada

Site Status

Hamilton Health Sciences, Henderson

Hamilton, Ontario, Canada

Site Status

Hamilton Health Sciences, General

Hamilton, Ontario, Canada

Site Status

SMBD Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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Linkins LA, Bates SM, Lang E, Kahn SR, Douketis JD, Julian J, Parpia S, Gross P, Weitz JI, Spencer FA, Lee AY, O'Donnell MJ, Crowther MA, Chan HH, Lim W, Schulman S, Ginsberg JS, Kearon C. Selective D-dimer testing for diagnosis of a first suspected episode of deep venous thrombosis: a randomized trial. Ann Intern Med. 2013 Jan 15;158(2):93-100. doi: 10.7326/0003-4819-158-2-201301150-00003.

Reference Type DERIVED
PMID: 23318311 (View on PubMed)

Other Identifiers

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Grant Number: NA 5429

Identifier Type: -

Identifier Source: secondary_id

CTMG-2005-SELECT

Identifier Type: -

Identifier Source: org_study_id