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Deferment of Imaging for Pulmonary Embolism

NCT00381511 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2006-10-17

No results posted yet for this study

Summary

Background. Management of patients with suspected Pulmonary Embolism (PE) is problematic if diagnostic imaging is not available. Pretest Clinical Probability (PCP) and D-dimer (D-d) assessment were shown to be useful to identify those high risk patients for whom empirical, protective anticoagulation is indicated.

To evaluate whether PCP and D-d assessment, together with the use of low molecular weight heparins (LMWHs), allow objective appraisal of PE to be deferred for up to 72 hours, we planned to prospectively evaluate consecutive patients with suspected PE.

Methods. In case of deferment of diagnostic imaging for PE, patients identified at high-risk (those with high PCP or moderate PCP and positive D-d), receive a protective full-dose treatment of LMWH; the remaining patients will be discharged without anticoagulant. All patients will be scheduled to undergo objective tests for PE within 72 hours. Standard antithrombotic therapy will be then administered when diagnostic tests confirmed Venous ThromboEmbolism (VTE).

Conditions

Interventions

DRUG

low molecular weight heparin

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Policlinico

    lead OTHER

Principal Investigators

  • Sergio Siragusa, MD · University Hospital of Palermo

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-01-31
Completion
2004-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00381511 on ClinicalTrials.gov