Deep Vein ThrombosisPhase 3NCT00182247
D-Dimer and IPG for Recurrent Thrombosis (DIRECT)
A Phase 3 study testing venogram in people with Deep Vein Thrombosis and Pulmonary Embolism, run by Hamilton Health Sciences Corporation at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Pulmonary Embolism
- What is being tested?
- venogram
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Dec 1998to Jan 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- suspected deep vein thrombosis
- history of previous DVT or PE
Who cannot join
- 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
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Canada7 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
St. Joseph' Hospital
Hamilton, Ontario, L8N 4A6
Henderson General Hospital
Hamilton, Ontario, L8V 1C3
Chedoke Hospital
Hamilton, Ontario
London Health Sciences Centre
London, Ontario, N6A 4G5
CHA - Pavillon Saint-Sacrement
Québec, Quebec, G1S 4L8
About this study
Official title: D-Dimer and IPG for Recurrent Thrombosis (DIRECT) Study
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.
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Being tested
- venogram
- Keywords
- deep vein thrombosis, DVT, pulmonary embolism, PE, venous thromboembolism, VTE, d-dimer, IPG
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venogramProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
symptomatic DVT and PE in follow-up
Secondary outcomes (3)
death
deep vein thrombosis diagnosed by venography in those
randomized to that intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 1998
- Study completionJan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Investigators
- Shannon Bates, M.D., Study chair, Hamilton Health Sciences CorporationJeffrey Ginsberg, M.D., Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182247
- Sponsor's protocol ID
- CTMG-1998-DIRECT
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 16 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-Dimer and IPG for Recurrent Thrombosis (DIRECT) Study
- ClinicalTrials.gov ID
- NCT00182247
- Acronym / sponsor ID
- CTMG-1998-DIRECT
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Keywords
- deep vein thrombosis, DVT, pulmonary embolism, PE, venous thromboembolism, VTE, d-dimer, IPG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 600 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- Dec 1998
- Study completion
- Jan 2001
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- suspected deep vein thrombosis
- history of previous DVT or PE
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venogram | Procedure or surgery | – |
Primary outcome
symptomatic DVT and PE in follow-up
3 secondary outcomes
death
deep vein thrombosis diagnosed by venography in those
randomized to that intervention
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Bates, M.D. study chair
Hamilton Health Sciences Corporation
Jeffrey Ginsberg, M.D. principal investigator
Hamilton Health Sciences Corporation
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing venogram in people with Deep Vein Thrombosis and Pulmonary Embolism, run by Hamilton Health Sciences Corporation at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptomatic DVT and PE in follow-up. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2005.