NCT00157677

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,727

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

October 27, 2011

Status Verified

October 1, 2011

Enrollment Period

5.7 years

First QC Date

September 8, 2005

Last Update Submit

October 25, 2011

Conditions

Deep Vein Thrombosis

Keywords

deep vein thrombosispulmonary embolismD-dimer testing

Outcome Measures

Primary Outcomes (1)

  • 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

    3 Months

Secondary Outcomes (3)

  • bleeding

    3 Months

  • healthcare utilization

    3 Months

  • cost-effectiveness

    3 Months

Study Arms (2)

1

EXPERIMENTAL

Selective D-Dimer use

Procedure: D-dimer testing

2

ACTIVE COMPARATOR

Uniform D-Dimer use

Procedure: D-dimer testing

Interventions

D-dimer testingPROCEDURE

Uniform D-dimer use

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and older
  • Presenting with symptoms compatible with clinically suspected deep vein thrombosis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hamilton Health Sciences, McMaster

Hamilton, Ontario, L8N 3Z5, Canada

Location

St. Joseph's Health Care Centre

Hamilton, Ontario, L8N 4A6, Canada

Location

Hamilton Health Sciences, Henderson

Hamilton, Ontario, L8V 1C3, Canada

Location

Hamilton Health Sciences, General

Hamilton, Ontario, Canada

Location

SMBD Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 23318311DERIVED

MeSH Terms

Conditions

Venous ThrombosisPulmonary Embolism

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Study Officials

  • Lori Linkins, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Clive Kearon, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Jim Julian, MMath

    McMaster University, Dept. of Clinical Epidemiology and Biostatistics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

October 1, 2004

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

October 27, 2011

Record last verified: 2011-10

Locations

CA(5)