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

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

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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