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

NCT01626521 | Unknown DMC

• 1 other identifier: 0033-12-HYMC
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• Negative Predictive Value of Prothrombin Fragment F1+2

  Blood test to determine predictive value of Prothrombin Fragment F1+2 in PE diagnosis in hospitalized COPD patients

  Six months

Study Arms (1)

COPD Exacerbation

Patients admitted to hospital with COPD exacerbation

Other: CT pulmonary angio, blood tests

Interventions

CT pulmonary angio, blood tests OTHER

CT pulmonary angiography to determine PE and laboratory blood tests to determine prothrombin fragments F1+2 in blood of COPD patients

COPD Exacerbation

Eligibility Criteria

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

Study Population

Patients admitted to hospital due to COPD exacerbation

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pulmonary Embolism

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Ihab Abdelhai, MD

CONTACT

972-4-630-4525; ihababdelhai69@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2012
• First Posted: June 22, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

IL (1)