Deep Vein ThrombosisPhase 3NCT00182351
D-Dimer Vs Serial Compression Ultrasound Study
A Phase 3 study testing D-dimer and Serial Compression Ultrasound in people with Deep Vein Thrombosis, run by Hamilton Health Sciences Corporation at 3 sites in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- D-dimer and Serial Compression Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 810 participants
- Where
- 3 sitesCanada
- Study dates
- Apr 1996to Jul 1999
- 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
- first suspected deep vein thrombosis
- no previous venous thromboembolism
- referred to thromboembolism outpatient clinic
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Hamilton Health Sciences - Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
St. Joseph's Hospital
Hamilton, Ontario, L8N 4A6
Hamilton Health Sciences - Henderson Hospital
Hamilton, Ontario, L8V 1C3
About this study
Official title: Evaluation of the Safety, Efficacy and Cost-Effectiveness of Two Strategies for the Diagnosis of Deep Vein Thrombosis
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
- Conditions
- Deep Vein Thrombosis
- Being tested
- D-dimer, Serial Compression Ultrasound
- Keywords
- deep vein thrombosis, d-dimer, serial compression ultrasound
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-dimerProcedure or surgery
Serial Compression UltrasoundProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of withholding anticoagulants
Secondary outcomes (3)
deep vein thrombosis
pulmonary embolism
death
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 startApr 1996
- Study completionJul 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 810 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Health Canada
- Investigators
- Clive Kearon, MB, Study chair, Hamilton Health Sciences and McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182351
- Sponsor's protocol ID
- CTMG-1995-DDCUS
- Status last verified
- Sep 2006
- First submitted
- 13 Sep 2005
- Last updated
- 8 Sep 2006
- Results posted
- No
Publications
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.
PubMed 15809460
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety, Efficacy and Cost-Effectiveness of Two Strategies for the Diagnosis of Deep Vein Thrombosis
- ClinicalTrials.gov ID
- NCT00182351
- Acronym / sponsor ID
- CTMG-1995-DDCUS
- Conditions
- Deep Vein Thrombosis
- Keywords
- deep vein thrombosis, d-dimer, serial compression ultrasound
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 810 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Health Canada
- Study start
- Apr 1996
- Study completion
- Jul 1999
- 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 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
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 (3 listed)
- first suspected deep vein thrombosis
- no previous venous thromboembolism
- referred to thromboembolism outpatient clinic
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| D-dimer | Procedure or surgery | – |
| Serial Compression Ultrasound | Procedure or surgery | – |
Primary outcome
safety of withholding anticoagulants
3 secondary outcomes
deep vein thrombosis
pulmonary embolism
death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2006.
- Results publication: PubMed 15809460Kearon 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.
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SAFELY RULING OUT DEEP VEIN THROMBOSIS IN PREGNANCY WITH THE LEFt SCORE AND TRIMESTER-ADJUSTED D-DIMER CUTOFFS (the PREG-DVT Study): A PROSPECTIVE COHORT STUDY.
Pregnancy Related, Deep Vein Thrombosis
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.
Clive Kearon, MB study chair
Hamilton Health Sciences and McMaster University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing D-dimer and Serial Compression Ultrasound in people with Deep Vein Thrombosis, run by Hamilton Health Sciences Corporation at 3 sites in Canada.
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 3 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: finished, as of the sponsor's last update on 8 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
safety of withholding anticoagulants. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182351, which also lists 1 linked publication.
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 8 Sep 2006.