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Age-adjusted D-dimer cut-off levels to rule out pulmonary embolism: a prospective outcome study.

Conditions
pulmonary embolism, D-dimer test, diagnosis, efficacy, elderly
Registration Number
NL-OMON27990
Lead Sponsor
Academic Medical Center in collaboration with centers in The Netherlands, France, Switzerland and Belgium
Brief Summary

1. Douma RA, le Gal G, Söhne M, Righini M, Kamphuisen PW, Perrier A, Kruip MJHA, Bounameaux H, Büller HR, Roy PM. Age-adjusted D-dimer cut-off levels increase the ability to safely rule out pulmonary embolism in older patients: a retrospective analysis of three large management study cohorts. BMJ, in press<br> 2. van Belle A, Büller HR, Huisman MV, Huisman PM, Kaasjager K, Kamphuisen PW, Kramer MH, Kruip MJ, Kwakkel-van Erp JM, Leebeek FW, Nijkeuter M, Prins MH, Sohne M, Tick LW. Effectiveness of managing suspected pulmonary embolism using an algorithm combining clinical probability, D-dimer testing, and computed tomography. JAMA 2006;295:172-9.<br> 3. Djurabi RK, Klok FA, Nijkeuter M, Kaasjager K, Kamphuisen PW, Kramer MH, Kruip MJ, Leebeek FW, Büller HR, Huisman MV. Comparison of the clinical usefulness of two quantitative D-Dimer tests in patients with a low clinical probability of pulmonary embolism. Thromb Res 2009;123:771-4.<br> 4. Huisman MV, Klok FA. Diagnostic management of clinically suspected acute pulmonary embolism. J Thromb Haemost 2009;7 Suppl 1:312-7.<br> 5. Klok FA, Mos IC, Nijkeuter M, Righini M, Perrier A, Le Gal G, Huisman MV. Simplification of the revised Geneva score for assessing clinical probability of pulmonary embolism. Arch Intern Med 2008;168:2131-6.

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
2400
Inclusion Criteria

All outpatients >50 years admitted to the emergency ward for suspected pulmonary embolism defined as acute onset of new or worsening shortness of breath or chest pain without another obvious etiology will be included in the study, provided they have signed an informed consent form.

Exclusion Criteria

1. PE suspicion raised more than 24 hours after admission to the hospital;

2. Absence of informed consent;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The number of thromboembolic events in the 3-month follow-up period in patients not anticoagulated on the basis of:<br /><br>1. A non high clinical probability (simplified revised Geneva score) and a normal new age adjusted D-dimer cut-off, or;<br /><br>2. A PE considered as unlikely (simplified wells score) and a normal new age adjusted D-dimer cut-off.
Secondary Outcome Measures
NameTimeMethod
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