search
Back to results

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

Primary Purpose

Deep Vein Thrombosis

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
D-dimer testing
D-dimer testing
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Deep Vein Thrombosis focused on measuring deep vein thrombosis, pulmonary embolism, D-dimer testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hamilton Health Sciences, McMaster
  • St. Joseph's Health Care Centre
  • Hamilton Health Sciences, Henderson
  • Hamilton Health Sciences, General
  • SMBD Jewish General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Selective D-Dimer use

Uniform D-Dimer use

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

bleeding
healthcare utilization
cost-effectiveness

Full Information

First Posted
September 8, 2005
Last Updated
October 25, 2011
Sponsor
McMaster University
Collaborators
Heart and Stroke Foundation of Ontario
search

1. Study Identification

Unique Protocol Identification Number
NCT00157677
Brief Title
Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis (SELECT)
Acronym
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

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Heart and Stroke Foundation of Ontario

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis
Keywords
deep vein thrombosis, pulmonary embolism, D-dimer testing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1727 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Selective D-Dimer use
Arm Title
2
Arm Type
Active Comparator
Arm Description
Uniform D-Dimer use
Intervention Type
Procedure
Intervention Name(s)
D-dimer testing
Intervention Description
Uniform D-dimer use
Intervention Type
Procedure
Intervention Name(s)
D-dimer testing
Intervention Description
Selective D-Dimer use
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
bleeding
Time Frame
3 Months
Title
healthcare utilization
Time Frame
3 Months
Title
cost-effectiveness
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Linkins, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Clive Kearon, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jim Julian, MMath
Organizational Affiliation
McMaster University, Dept. of Clinical Epidemiology and Biostatistics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences, McMaster
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
St. Joseph's Health Care Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Hamilton Health Sciences, Henderson
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Hamilton Health Sciences, General
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
SMBD Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23318311
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs