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Deferment of Imaging for Pulmonary Embolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00381511
Recruitment Status : Completed
First Posted : September 28, 2006
Last Update Posted : October 17, 2006
Sponsor:
Information provided by:
Azienda Ospedaliera Universitaria Policlinico

Brief 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).


Condition or disease Intervention/treatment Phase
Pulmonary Embolism Drug: low molecular weight heparin Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Objective Assessment of Pulmonary Embolism Can be Deferred Without Increased Risk
Study Start Date : January 1999
Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Heparin




Primary Outcome Measures :
  1. Recurrent venous thromboembolism
  2. major bleeding
  3. death


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Out-patients presenting with suspected acute PE, when diagnostic imaging are not immediately available (during nights or week-ends), are considered eligible for the study.

Exclusion Criteria:

  • life-threatening conditions, or serious co-morbidities that required immediate hospitalisation ;
  • relapse of a previously documented PE episode;
  • current use of oral anticoagulant therapy;
  • history of bleeding or any other contraindication to heparin;
  • age younger than 18 years;
  • life expectancy of less than 3 months;
  • refusal to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381511


Sponsors and Collaborators
Azienda Ospedaliera Universitaria Policlinico
Investigators
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Principal Investigator: Sergio Siragusa, MD University Hospital of Palermo

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ClinicalTrials.gov Identifier: NCT00381511    
Other Study ID Numbers: 3090A-101657
First Posted: September 28, 2006    Key Record Dates
Last Update Posted: October 17, 2006
Last Verified: September 2006
Keywords provided by Azienda Ospedaliera Universitaria Policlinico:
pulmonary embolism,
deferred diagnosis,
protective anticoagulation
anticoagulants
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action