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
• Interventions: Other: CT pulmonary angio, blood tests

• 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

Arm && Interventions

Group	Intervention	Description
COPD Exacerbation	CT pulmonary angio, blood tests	Patients admitted to hospital with COPD exacerbation

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