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 because the information has not been verified recently.
Verified June 2012 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01626521
First received: June 17, 2012
Last updated: June 21, 2012
Last verified: June 2012
  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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01626521     History of Changes
Other Study ID Numbers: 0033-12-HYMC
Study First Received: June 17, 2012
Last Updated: June 21, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on September 29, 2014