Value of Prothrombin Fragment F1+2 in the Diagnosis of Pulmonary Embolism in Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

• Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Embolism

• Registration Number: NCT01626521
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

To access the clinical usefulness of F1+2 in the diagnosis of PE in patients with AECOPD who require hospitalization. Specifically, to determine whether F1+2 may have an additional value in the subgroup of patients with an abnormal D-dimer,to determine whether it may increase the proportion of patients in whom PE can be safely ruled out and to determine the sensitivity, specificity and NPV of F1+2 at various cut-off values.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-06
• Study First Submitted: 2012-06-17
• Study First Submitted QC: 2012-06-21
• Last Update Submitted: 2012-06-21
• Study First Posted: 2012-06-22
• Last Update Posted: 2012-06-22
• Study Start: 2012-07
• Primary Completion: 2013-01
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• COPD exacerbation
• Able to give informed consent
• Able to perform spirometry

Exclusion Criteria

• Known malignancy
• Known hypercoagulable state
• Receiving anticoagulant treatment
• Pregnancy
• Renal failure
• Allergy to iodine

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Negative Predictive Value of Prothrombin Fragment F1+2	Six months	Blood test to determine predictive value of Prothrombin Fragment F1+2 in PE diagnosis in hospitalized COPD patients

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel