Deferment of Imaging for Pulmonary Embolism
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|ClinicalTrials.gov Identifier: NCT00381511|
Recruitment Status : Completed
First Posted : September 28, 2006
Last Update Posted : October 17, 2006
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|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Objective Assessment of Pulmonary Embolism Can be Deferred Without Increased Risk|
|Study Start Date :||January 1999|
|Study Completion Date :||April 2004|
- Recurrent venous thromboembolism
- major bleeding
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
|Principal Investigator:||Sergio Siragusa, MD||University Hospital of Palermo|