Evaluation of four clinical decision rules to exclude a pulmonary embolism (Wells rule, revised Geneva score, simplified Wells rule and the simplified revised Geneva score). Evaluation if it is safe and easy to use this rules.Beside this, the…
ID
Source
Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(Recurrent) pulmonary embolism or a deep vein thrombosis during three months
follow-up in the groups of patients in which a pulmonary embolism is excluded
by the clinical decision rules and D-dimer or by CT scan.
Secondary outcome
Not applicable
Background summary
A combination of different tests is used to diagnose or exclude a pulmonary
embolism. The clinical decision rule (according to Wells), a D-dimer and a
CT-scan. The usefulness of this combination is approved in other studies with
patients with a suspicion of a fist pulmonary embolism. Another rule is
developed (the revised Geneva score) and a simplified version is made of both
rules (the Wells and revised Geneva score), in which each item gets only one
point. It is possible that with one of this new rules it is safer or easier to
exclude a pulmonary embolism than happens until now. And maybe less CT-scans
are necessary in the future.
It is uncertain if the standard combination of tests can safely exclude a
recurrent pulmonary embolism.
Study objective
Evaluation of four clinical decision rules to exclude a pulmonary embolism
(Wells rule, revised Geneva score, simplified Wells rule and the simplified
revised Geneva score). Evaluation if it is safe and easy to use this rules.
Beside this, the clinical decision rule according to Wells is evaluated in
patients with a suspected recurrent pulmonary embolism, if it is safe to
withholding treatment with anticoagulants in case of exclusion of a pulmonary
embolism.
Study design
Prospective multi- centre cohort study
Twelve hospitals are participating.
Study burden and risks
During the diagnostic process, one additional tube of blood is obtained to test
for factors that may be of influence on the development or the diagnostic
process of a pulmonary embolism, it is not a DNA test.
In the group of patients in which the clinical decision rules disagree, an
additional CT scan is performed. This would not be a standard procedure without
this study. Because of this study, 23% additional scans are performed. The
effective dose of a single CT varies between 2.8 and 3.9 mSV. The risks of this
additional radiation depends on the age of the patient.
Beside this two tests, a patient is called after three months with the question
if in the meanwhile a pulmonary embolism or a deep vein thrombosis developed.
This phone call takes 5 minutes of time.
Postbus 9600
2300 RC Leiden
NL
Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
Patients with clinically suspected pulmonary embolism
Exclusion criteria
Age < 18 Years
LMWH or unfractionated heparin 24 hours or more prior to eligibility assesment
Vitamin K antagonists (coumarin derivates)
Allergy to intravenous iodinated contrast
Renal insufficiency (estimated creatinine clearance < 30 ml/min)
Preagnancy
Life expectancy < 3 months
Impossibility to return for follow-up
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL21228.058.07 |