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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01626521
First Posted: June 22, 2012
Last Update Posted: June 22, 2012
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.
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
  Purpose
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 Intervention
Chronic Obstructive Pulmonary Disease Pulmonary Embolism Other: CT pulmonary angio, blood tests

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01626521


Contacts
Contact: Ihab Abdelhai, MD 972-4-630-4525 ihababdelhai69@gmail.com

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

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01626521     History of Changes
Other Study ID Numbers: 0033-12-HYMC
First Submitted: June 17, 2012
First Posted: June 22, 2012
Last Update Posted: June 22, 2012
Last Verified: June 2012

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