Deferment of Imaging for Pulmonary Embolism

NCT00381511 | Completed Phase 4

• 1 other identifier: 3090A-101657
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pulmonary Embolism

Keywords

pulmonary embolism,; deferred diagnosis,; protective anticoagulation; anticoagulants

Outcome Measures

Primary Outcomes (3)

• Recurrent venous thromboembolism

• major bleeding

• death

Interventions

low molecular weight heparin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico: lead

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Sergio Siragusa, MD

  University Hospital of Palermo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 27, 2006
• First Posted: September 28, 2006
• Study Start: January 1, 1999
• Study Completion: April 1, 2004
• Last Updated: October 17, 2006

Record last verified: 2006-09