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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01626521
Recruitment Status : Unknown
Verified June 2012 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 22, 2012
Last Update Posted : June 22, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Pulmonary Embolism Other: CT pulmonary angio, blood tests

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : July 2012
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
COPD Exacerbation
Patients admitted to hospital with COPD exacerbation
Other: CT pulmonary angio, blood tests
CT pulmonary angiography to determine PE and laboratory blood tests to determine prothrombin fragments F1+2 in blood of COPD patients

Primary Outcome Measures :
  1. Negative Predictive Value of Prothrombin Fragment F1+2 [ Time Frame: Six months ]
    Blood test to determine predictive value of Prothrombin Fragment F1+2 in PE diagnosis in hospitalized COPD patients

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to hospital due to COPD exacerbation

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01626521

Contact: Ihab Abdelhai, MD 972-4-630-4525

Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Principal Investigator: Marinela Beckerman, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center

Responsible Party: Hillel Yaffe Medical Center Identifier: NCT01626521     History of Changes
Other Study ID Numbers: 0033-12-HYMC
First Posted: June 22, 2012    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Embolism
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases