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NCT01626521 Clinical Trial

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

Chronic Obstructive Pulmonary Disease Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01626521
Other study ID # 0033-12-HYMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 17, 2012
Last updated June 21, 2012
Start date July 2012
Est. completion date January 2013

Study information
Verified date June 2012
Source Hillel Yaffe Medical Center
Contact Ihab Abdelhai, MD
Phone 972-4-630-4525
Email ihababdelhai69@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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