No registrations found.
ID
Source
Brief title
Health condition
Clinically suspected pulmonary embolism.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patients, in whom pulmonary embolism was excluded, were followed up for 3 months to document the occurrence of venous thromboembolic events or death.
Secondary outcome
N/A
Background summary
In conclusion, this large study has prospectively demonstrated the safety of excluding pulmonary embolism by the use of a dichotomous clinical decision rule and D-dimer test in patients with suspected pulmonary embolism. We have established that by implying such a non-invasive strategy anticoagulant therapy can safely be withheld with great efficiency involving more than 50 % of patients, thus obviating the need for more invasive and costly tests, including CT scan and perfusion lung scan. The standard approach in the diagnostic management of PE should now be to start with a clinical decision rule and a quantitative D-dimer test and rely on the outcome of these two tests. If the clinical decision rule indicates PE to be likely present or if the D-dimer test is abnormal, further imaging tests are warranted.
Study objective
Excluding PE by a CDR indicating PE unlikely, assessed by the Wells simplified decision rule, combined with a normal D-dimer is safe and efficient.
Study design
N/A
Intervention
Upon clinical suspicion, Wells clinical decision rule was performed first and if patients had a score of 4.0 points, a D-dimer test followed. Patients with a normal D-dimer concentration had no further tests, pulmonary embolism was considered excluded and patients did not receive anticoagulant treatment.
C1-45
PO-box 9600
R.J. Goekoop
Leiden 2300 RC
The Netherlands
+31 (0)71 5269111
r.j.goekoop@lumc.nl
C1-45
PO-box 9600
R.J. Goekoop
Leiden 2300 RC
The Netherlands
+31 (0)71 5269111
r.j.goekoop@lumc.nl
Inclusion criteria
Outpatients with clinically suspected PE.
Exclusion criteria
1. Anticoagulant therapy for more than 24 hours;
2. aged under 18 years;
3. pregnancy;
4. allergy to contrast media;
5. expected survival less than 3 months;
6. venous thromboembolism in the previous 6 months;
7. refusal or inability to consent.
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 |
---|---|
NTR-new | NL747 |
NTR-old | NTR757 |
Other | : N/A |
ISRCTN | ISRCTN10533382 |