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

October 25, 2011 updated by: McMaster University

Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis: A Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1727

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Selective D-Dimer use
Procedure: D-dimer testing
Uniform 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
Procedure: D-dimer testing
Selective D-Dimer use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
bleeding
Time Frame: 3 Months
3 Months
healthcare utilization
Time Frame: 3 Months
3 Months
cost-effectiveness
Time Frame: 3 Months
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Heart and Stroke Foundation of Ontario

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

October 27, 2011

Last Update Submitted That Met QC Criteria

October 25, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTMG-2005-SELECT
  • Grant Number: NA 5429

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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