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Prometheus-Study: Diagnostics.

Prometheus-Study: Diagnostics.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26276
Enrollment
800
Registered
2010-01-27
Start date
2008-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary embolism diagnosis clinical decision rule

Interventions

In 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
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 (figu
2. A combination of a low probability of the Wells score and an abnormal D-dimer.

Sponsors

LUMC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Out- or inpatients with a first episode of clinically suspected pulmonary embolism; 2. Suspected recurrent pulmonary embolism for study question B.

Exclusion criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

MeasureTime frame
(Recurrent) pulmonary embolism or deep vein thrombosis.

Secondary

MeasureTime frame
Performance of four clinical decision rules.

Contacts

Public ContactM.V. Huisman

Leiden University Medical Center (LUMC) Department of Thrombosis and Haemostasis Room C4-68 P.O Box 9600

m.v.huisman@lumc.nl+31 (0)71 5262085

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)