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van CCT (UK)


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van CCT (UK)


Simple and safe exclusion of pulmonary embolism using quantitative D-dimer and Wells simplified decision rule.


- candidate number2223
- NTR NumberNTR757
- ISRCTNISRCTN10533382
- Date ISRCTN created22-nov-2006
- date ISRCTN requested8-nov-2006
- Date Registered NTR30-aug-2006
- Secondary IDsN/A 
- Public TitleSimple and safe exclusion of pulmonary embolism using quantitative D-dimer and Wells simplified decision rule.
- Scientific TitleSimple and safe exclusion of pulmonary embolism using quantitative D-dimer and Wells simplified decision rule.
- ACRONYMN/A
- hypothesisExcluding PE by a CDR indicating PE unlikely, assessed by the Wells simplified decision rule, combined with a normal D-dimer is safe and efficient.
- Healt Condition(s) or Problem(s) studiedPulmonary embolism, clinically suspected
- Inclusion criteriaOutpatients with clinically suspected PE.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-mrt-2002
- planned closingdate1-jun-2004
- Target number of participants879
- InterventionsUpon 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.
- Primary outcomePatients, in whom pulmonary embolism was excluded, were followed up for 3 months to document the occurrence of venous thromboembolic events or death.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. R.J. Goekoop
- CONTACT for SCIENTIFIC QUERIESMD. R.J. Goekoop
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of General Internal Medicine
- Funding
(Source(s) of Monetary or Material Support)
Unrestricted grants from the participating hospitals
- PublicationsThromb Haemost. 2007 Jan;97(1):146-50.
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD30-aug-2006 - 12-jun-2008


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