NCT00182351

Brief Summary

To determine whether d-dimer testing can be used to simplify and reduce the costs of the diagnostic approach to patients with clinically suspected deep vein thrombosis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
810

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 1996

Typical duration for phase_3

Geographic Reach
1 country

3 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

April 1, 1996

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 1999

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

September 8, 2006

Status Verified

September 1, 2006

First QC Date

September 13, 2005

Last Update Submit

September 7, 2006

Conditions

Deep Vein Thrombosis

Keywords

deep vein thrombosisd-dimerserial compression ultrasound

Outcome Measures

Primary Outcomes (1)

  • safety of withholding anticoagulants

Secondary Outcomes (3)

  • deep vein thrombosis

  • pulmonary embolism

  • death

Interventions

D-dimerPROCEDURE
Serial Compression UltrasoundPROCEDURE

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • first suspected deep vein thrombosis
  • no previous venous thromboembolism
  • referred to thromboembolism outpatient clinic

You may not qualify if:

  • comorbid condition limiting survival to less than six months
  • contraindication to venography (contrast allergy, etc.)
  • receiving long term warfarin therapy
  • receiving full dose heparin therapy for more than 48 hours
  • absence of symptoms during the five days immediately prior to presentation
  • symptoms of pulmonary embolism
  • pregnancy
  • geographic inaccessibility which precludes follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hamilton Health Sciences - Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

St. Joseph's Hospital

Hamilton, Ontario, L8N 4A6, Canada

Location

Hamilton Health Sciences - Henderson Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location

Related Publications (1)

  • Kearon C, Ginsberg JS, Douketis J, Crowther MA, Turpie AG, Bates SM, Lee A, Brill-Edwards P, Finch T, Gent M. A randomized trial of diagnostic strategies after normal proximal vein ultrasonography for suspected deep venous thrombosis: D-dimer testing compared with repeated ultrasonography. Ann Intern Med. 2005 Apr 5;142(7):490-6. doi: 10.7326/0003-4819-142-7-200504050-00007.

    PMID: 15809460RESULT

MeSH Terms

Conditions

Venous Thrombosis

Interventions

fibrin fragment D

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Clive Kearon, MB

    Hamilton Health Sciences and McMaster University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

April 1, 1996

Study Completion

July 1, 1999

Last Updated

September 8, 2006

Record last verified: 2006-09

Locations

CA(3)