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Prometheus-Study: Diagnostics.


- candidate number7696
- NTR NumberNTR2185
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-jan-2010
- Secondary IDsP07.266 METC LUMC Leiden
- Public TitlePrometheus-Study: Diagnostics.
- Scientific TitlePrometheus-Study: Diagnostics.
- ACRONYM
- hypothesis1. To assess four different clinical decision rules (Wells rule, revised Geneva decision rule, simplified Wells rule and simplified revised Geneva decision rule) in the exclusion of pulmonary embolism;
2. To evaluate the safety of withholding anticoagulant treatment in patients in whom recurrent PE is excluded on the basis of a pre-specified algorithm (using the Wells rule).
- Healt Condition(s) or Problem(s) studiedPulmonary embolism, Diagnosis, Diagnostic work-up
- Inclusion criteria1. Out- or inpatients with a first episode of clinically suspected pulmonary embolism;
2. Suspected recurrent pulmonary embolism for study question B.
- Exclusion criteria1. Age < 18 years;
2. Life expectancy < 3 months;
3. Treatment with full-dose therapeutic low molecular weight heparin or unfractionated heparin that was initiated 24 hours or more prior to eligibility assessment;
4. Treatment with vitamin K antagonists (coumarin derivates);
5. Contraindication to helical CT:
A. Allergy to intravenous iodinated contrast;
B. Renal insufficiency (creatinine clearance < 30 ml/min);
C. Pregnancy;
D. Impossibility to return for follow-up.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jul-2008
- planned closingdate1-aug-2012
- Target number of participants800
- InterventionsIn case of a first PE, a CT scan is performed in the following combination of tests:
1. Decision rules disagree with each other (one (or more) indicating ‘unlikely’ probability, other(s) indicating a ‘likely’ probability);
2. All four decision rules indicate a ‘likely' probability for PE;
3. All four decision rules indicate an ‘unlikely’ probability for PE but D-dimer is abnormal.

In case of a recurrent pulmonary embolism, the Wells rule will prefer, a CT is performed in case of (figure 1b):
1. A high probability of the Wells score;
2. A combination of a low probability of the Wells score and an abnormal D-dimer.
- Primary outcome(Recurrent) pulmonary embolism or deep vein thrombosis.
- Secondary outcomePerformance of four clinical decision rules.
- TimepointsMoment of diagnostic workup for PE and 3 month follow up (one telephone call).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. M.V. Huisman
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M.V. Huisman
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryThe object of this study is to evaluate four clinical decision rules in the exclusion of pulmonary embolism (Wells rule, revised Geneva score, simplified Wells rule and simplified revised Geneva score). They will be evaluated for safety and clinical utility, both alone and in combination with a D-dimer test. Also, the clinical decision rule according to Wells is evaluated in patients with a suspected recurrent pulmonary embolism: whether it is safe to withhold anticoagulant treatment in patients in whom suspected recurrent pulmonary embolism is excluded based on an unlikely Wells score combined with a normal D-dimer test.
- Main changes (audit trail)
- RECORD27-jan-2010 - 9-feb-2010


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