NCT00157599

Brief Summary

To determine whether treatment and further investigation can be safely withheld in patients who present with suspected recurrent deep vein thrombosis (DVT) and have either a (i) negative D-Dimer or (ii) a positive D-Dimer with normal serial compression ultrasound.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Geographic Reach
2 countries

6 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

January 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

July 26, 2011

Status Verified

October 1, 2007

First QC Date

September 7, 2005

Last Update Submit

July 25, 2011

Conditions

Deep Vein Thrombosis

Keywords

deep vein thrombosisDVT

Outcome Measures

Primary Outcomes (2)

  • Suspected DVT during follow-up

  • Suspected PE during follow-up

Interventions

various diagnostic measures for DVT (e.g., CUS)PROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Age 18 or older
  • Currently suspected for recurrent DVT
  • Has a prior history of objectively documented DVT or PE

You may not qualify if:

  • Comorbid condition limiting survival to less than 3 months
  • History of hypersensitivity to contrast medium
  • Renal dysfunction with a creatinine of \> 150 mcmol/L
  • Treatment with full-dose therapeutic unfractionated or low molecular weight heparin that was initiated 24 hours or more prior to eligibility assessment
  • Pregnancy or lactation
  • Symptomatic for pulmonary embolism
  • Absence of symptoms within five days prior to presentation
  • Participation in another trial precluding the use of the diagnostic algorithm in this study
  • Geographically inaccessible for follow-up
  • Compression ultrasound, venogram, IPG, or D-dimer performed PRIOR to assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

McMaster University Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

Location

St. Joseph's Hospital

Hamilton, Ontario, L8N 4A6, Canada

Location

Henderson Research Centre

Hamilton, Ontario, L8V 1C3, Canada

Location

Sir Mortimer B. Davis Jewish General

Montreal, Quebec, H3T 1E2, Canada

Location

Academic Medical Centre

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

cupric sulfide

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Shannon Bates, M.D.

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

January 1, 2002

Study Completion

March 1, 2007

Last Updated

July 26, 2011

Record last verified: 2007-10

Locations

CA(5)NL(1)