Suspected Pulmonary EmbolismPhase 3NCT00182546
Canadian Pulmonary Embolism Diagnosis Study (CANPEDS)
A Phase 3 study testing Two diagnostic management strategies in people with Suspected Pulmonary Embolism and Deep Venous Thrombosis, run by Hamilton Health Sciences Corporation at 7 sites in Canada.
Trial summary
The main objective of the trial is to determine whether D-dimer testing combined with assessment of Pre-Test-Probability (using a standardized clinical model) can be used to markedly simplify the diagnostic process for PE. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Suspected Pulmonary Embolism, Deep Venous Thrombosis
- What is being tested?
- Two diagnostic management strategies
- Type of treatment
- Surgery or procedure
- How many people
- 1,126 participants
- Where
- 7 sitesCanada
- Study dates
- Aug 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
- Patients with clinically suspected PE
Who cannot join
- Treatment with anticoagulants for greater than 24 hours of performance of D-d
- Comorbid condition limiting survival to less than 3 months
- Absence of acute symptoms within 7 days prior to presentation
- Current pregnancy
- Contraindication to contrast (e.g., allergy, renal failure)
- Geographic inaccessibility which precludes follow-up
- Physician believes patient is inappropriate for study
- failure or inability to provide informed consent
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Queen Elizabeth II Health Sciences Ctr.
Halifax, Nova Scotia, B3H 1V7
Alexander G. Turpie
Hamilton, Ontario, L8L 2X2
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
James Douketis
Hamilton, Ontario, L8N 4A6
HHSC Henderson Campus
Hamilton, Ontario, L8V 1C3
London Health Sciences Centre
London, Ontario, N6A 4G5
Ottawa Civic Hospitals
Ottawa, Ontario, K1Y 1J8
About this study
Official title: Canadian Pulmonary Embolism Diagnosis Study
The main objective of the trial is to determine whether D-dimer testing combined with assessment of Pre-Test-Probability (using a standardized clinical model) can be used to markedly simplify the diagnostic process for PE.
It may be safe to omit additional diagnostic testing in selected patients with suspected pulmonary embolism who have a negative D-dimer test
Read the detailed description
To assess the value of the D-dimer in the diagnosis of PE, we had two sub-groups of patients with suspected PE, low and high pre-test probability. Patients could be randomized either to further or no further testing.
- Being tested
- Two diagnostic management strategies
- Keywords
- Pulmonary Embolism, DVT, Venous Thrombosis, D dimer, DD, Thrombosis, Diagnosis
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism, Thrombosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two diagnostic management strategiesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
DVT or PE during 6 months follow-up
Secondary outcomes (1)
bleeding
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 startAug 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 Suspected Pulmonary EmbolismStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,126 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Clive Kearon, MD, PhD, Study chair, McMaster UniversityJeffrey S Ginsberg, MD, Principal investigator, McMaster UniversityJames Douketis, MD, Principal investigator, McMaster UniversityAlexander G Turpie, MB, Principal investigator, McMaster UniversityShannon M Bates, MDCM, Principal investigator, McMaster UniversityMark A Crowther, MD, Principal investigator, McMaster UniversityJeffrey I Weitz, MD, Principal investigator, McMaster UniversityMichael Gent, DSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182546
- Sponsor's protocol ID
- CTMG-1999-CANPEDS
- Other IDs
- CIHR-CANPEDS
- Status last verified
- Aug 2005
- First submitted
- 13 Sep 2005
- Last updated
- 3 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Pulmonary Embolism Diagnosis Study
- ClinicalTrials.gov ID
- NCT00182546
- Acronym / sponsor ID
- CTMG-1999-CANPEDS
- Keywords
- Pulmonary Embolism, DVT, Venous Thrombosis, D dimer, DD, Thrombosis, Diagnosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1,126 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 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.
The main objective of the trial is to determine whether D-dimer testing combined with assessment of Pre-Test-Probability (using a standardized clinical model) can be used to markedly simplify the diagnostic process for PE.
It may be safe to omit additional diagnostic testing in selected patients with suspected pulmonary embolism who have a negative D-dimer test
Detailed description
To assess the value of the D-dimer in the diagnosis of PE, we had two sub-groups of patients with suspected PE, low and high pre-test probability. Patients could be randomized either to further or no further testing.
Study design
- Primary purpose
- Treatment
- 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 (1 listed)
- Patients with clinically suspected PE
Key exclusion criteria (8 listed)
- Treatment with anticoagulants for greater than 24 hours of performance of D-d
- Comorbid condition limiting survival to less than 3 months
- Absence of acute symptoms within 7 days prior to presentation
- Current pregnancy
- Contraindication to contrast (e.g., allergy, renal failure)
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 |
|---|---|---|
| Two diagnostic management strategies | Procedure or surgery | – |
Primary outcome
DVT or PE during 6 months follow-up
1 secondary outcome
bleeding
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 3 May 2006.
Related trials for Suspected Pulmonary Embolism
RecruitingObservational study
Clinical Management and Outcomes After Lung Scintigraphy for Suspected Pulmonary Embolism in the Emergency Department
Pulmonary Embolism (Diagnosis)
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, MD, PhD study chair
McMaster University
Jeffrey S Ginsberg, MD principal investigator
McMaster University
James Douketis, MD principal investigator
McMaster University
7 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 Two diagnostic management strategies in people with Suspected Pulmonary Embolism and Deep Venous Thrombosis, run by Hamilton Health Sciences Corporation at 7 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 1 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 3 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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?
DVT or PE during 6 months 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 3 May 2006.