D-Dimer and IPG for Recurrent Thrombosis (DIRECT) | NCT00182247

Studies
D-Dimer and IPG for Recurrent Thrombosis (DIRECT)

NCT00182247

Sponsor

Hamilton Health Sciences Corporation

Status

Terminated

Last Update Posted

Sep 16, 2005Estimated

Enrollment

600

Phase

Phase 3

Conditions

Deep Vein Thrombosis
Pulmonary Embolism

Interventions

venogram

Countries

Canada
Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1998

Primary Completion Date

Not provided

Completion Date

Jan 2001

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2005

Last Update Posted Date

Sep 16, 2005Estimated

Name	Class
Heart and Stroke Foundation of Canada	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600

Name	Type	Description	Arm Group Labels	Other Names
venogram	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
symptomatic DVT and PE in follow-up

Secondary Outcomes

Measure	Description	Time Frame
death
deep vein thrombosis diagnosed by venography in those
randomized to that intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

suspected deep vein thrombosis
history of previous DVT or PE

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shannon Bates, M.D.	Hamilton Health Sciences Corporation	Study Chair
Jeffrey Ginsberg, M.D.	Hamilton Health Sciences Corporation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hamilton General Hospital		Hamilton	Ontario	L8L 2X2	Canada
McMaster University Medical Centre

Condition Browse Module

MeSH Terms

ID	Term
D020246	Venous Thrombosis
D011655	Pulmonary Embolism
D054556	Venous Thromboembolism

Ancestor Terms

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided