NCT00182247

Brief Summary

To simplify and improve the diagnostic approach to patients with clinically suspected recurrent DVT by determining whether the results of the combination of IPG and d-dimer testing, using a whole blood agglutination assay, can be used in the management of such patients.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 1998

Geographic Reach
2 countries

8 active sites

Status
terminated

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

December 1, 1998

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2001

Completed
4.7 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 16, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Deep Vein ThrombosisPulmonary Embolism

Keywords

deep vein thrombosisDVTpulmonary embolismPEvenous thromboembolismVTEd-dimerIPG

Outcome Measures

Primary Outcomes (1)

  • symptomatic DVT and PE in follow-up

Secondary Outcomes (3)

  • death

  • deep vein thrombosis diagnosed by venography in those

  • randomized to that intervention

Interventions

venogramPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • suspected deep vein thrombosis
  • history of previous DVT or PE

You may not qualify if:

  • comorbid condition limiting survival to less than 6 months
  • contraindication to contrast medium (allergy, renal dysfunction, creatinine \> 150mcmol/L)
  • receiving long-term warfarin or heparin therapy
  • received full-dose heparin therapy for more than 48 hours
  • pregnancy
  • symptomatic for pulmonary embolism
  • absence of symptoms within 5 days of presentation
  • geographic inaccessibility which precludes follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

McMaster University Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

Location

St. Joseph' Hospital

Hamilton, Ontario, L8N 4A6, Canada

Location

Henderson General Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location

Chedoke Hospital

Hamilton, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

CHA - Pavillon Saint-Sacrement

Québec, Quebec, G1S 4L8, Canada

Location

IRCCS Policlinico S. Matteo

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Venous ThrombosisPulmonary EmbolismVenous Thromboembolism

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismThromboembolism

Study Officials

  • Shannon Bates, M.D.

    Hamilton Health Sciences Corporation

    STUDY CHAIR

  • Jeffrey Ginsberg, M.D.

    Hamilton Health Sciences Corporation

    PRINCIPAL INVESTIGATOR

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

December 1, 1998

Study Completion

January 1, 2001

Last Updated

September 16, 2005

Record last verified: 2005-09

Locations

IT(1)CA(7)