Deep Venous Thrombosis, Suspected Pulmonary Embolism
Conditions
Keywords
Pulmonary Embolism, DVT, Venous Thrombosis, D dimer, DD, Thrombosis, Diagnosis
Brief 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. 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.
Interventions
PROCEDURETwo diagnostic management strategies
Sponsors
Canadian Institutes of Health Research (CIHR)
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with clinically suspected PE
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DVT or PE during 6 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| bleeding | — |
Countries
Canada
Outcome results
None listed