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

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McMaster University

Status and phase

Completed
Phase 3

Conditions

Deep Vein Thrombosis

Treatments

Procedure: D-dimer testing

Study type

Interventional

Funder types

Other

Identifiers

NCT00157677
Grant Number: NA 5429
CTMG-2005-SELECT

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,727 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,727 participants in 2 patient groups

1
Experimental group
Description:
Selective D-Dimer use
Treatment:
Procedure: D-dimer testing
2
Active Comparator group
Description:
Uniform D-Dimer use
Treatment:
Procedure: D-dimer testing

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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