Clinical trial NCT00157677: Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis (SELECT)
Official title: Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Deep Vein Thrombosis
Keywords: deep vein thrombosis
pulmonary embolism
D-dimer testing
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2005-09-12
Enrollment: 1727
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: * 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 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.

Primary outcomes:
measure: 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
timeFrame: 3 Months
Secondary outcomes:
measure: bleeding
timeFrame: 3 Months
measure: healthcare utilization
timeFrame: 3 Months
measure: cost-effectiveness
timeFrame: 3 Months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences, McMaster
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Health Care Centre
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences, Henderson
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences, General
state: Ontario
city: Montreal
country: Canada
facility: SMBD Jewish General Hospital
state: Quebec
Study officials:
affiliation: McMaster University
name: Lori Linkins, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Clive Kearon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University, Dept. of Clinical Epidemiology and Biostatistics
name: Jim Julian, MMath
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.