Deep Vein ThrombosisNCT00157599
MDA D-Dimer / Recurrent DVT Study
A study testing various diagnostic measures for DVT (e.g., CUS) in people with Deep Vein Thrombosis, run by McMaster University at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- various diagnostic measures for DVT (e.g., CUS)
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jan 2002to Mar 2007
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Currently suspected for recurrent DVT
- Has a prior history of objectively documented DVT or PE
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Canada5 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
St. Joseph's Hospital
Hamilton, Ontario, L8N 4A6
Henderson Research Centre
Hamilton, Ontario, L8V 1C3
Sir Mortimer B. Davis Jewish General
Montreal, Quebec, H3T 1E2
About this study
Official title: A Cohort Study Evaluating the Safety of a Diagnostic Strategy Involving D-Dimer and Compression Ultrasonography in Patients With Suspected Recurrent Deep Vein Thrombosis
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.
- Conditions
- Deep Vein Thrombosis
- Being tested
- various diagnostic measures for DVT (e.g., CUS)
- Keywords
- deep vein thrombosis, DVT
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
various diagnostic measures for DVT (e.g., CUS)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Suspected DVT during follow-up
Suspected PE during follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2002
- Study completionMar 2007
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Shannon Bates, M.D., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157599
- Sponsor's protocol ID
- CTMG-2002-MDA
- Status last verified
- Oct 2007
- First submitted
- 7 Sep 2005
- Last updated
- 26 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study Evaluating the Safety of a Diagnostic Strategy Involving D-Dimer and Compression Ultrasonography in Patients With Suspected Recurrent Deep Vein Thrombosis
- ClinicalTrials.gov ID
- NCT00157599
- Acronym / sponsor ID
- CTMG-2002-MDA
- Conditions
- Deep Vein Thrombosis
- Keywords
- deep vein thrombosis, DVT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2002
- Study completion
- Mar 2007
- First posted
- 12 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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Currently suspected for recurrent DVT
- Has a prior history of objectively documented DVT or PE
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| various diagnostic measures for DVT (e.g., CUS) | Procedure or surgery | – |
Primary outcome
Suspected DVT during follow-up
Suspected PE during follow-up
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 26 Jul 2011.
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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. principal investigator
McMaster University
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing various diagnostic measures for DVT (e.g., CUS) in people with Deep Vein Thrombosis, run by McMaster University at 6 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 3 inclusion and 10 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 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, Netherlands. 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.
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?
Suspected DVT during follow-up. The study lists 2 primary outcomes in all. 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 26 Jul 2011.