- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01626521
Value of Prothrombin Fragment F1+2 in the Diagnosis of Pulmonary Embolism in Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
June 21, 2012 updated by: Hillel Yaffe Medical Center
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ihab Abdelhai, MD
- Phone Number: 972-4-630-4525
- Email: ihababdelhai69@gmail.com
Study Locations
-
-
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Hadera, Israel, 38100
- Hillel Yaffe Medical Center
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Principal Investigator:
- Marinela Beckerman, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients admitted to hospital due to COPD exacerbation
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
COPD Exacerbation
Patients admitted to hospital with COPD exacerbation
|
CT pulmonary angiography to determine PE and laboratory blood tests to determine prothrombin fragments F1+2 in blood of COPD patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Anticipated)
January 1, 2013
Study Completion (Anticipated)
January 1, 2013
Study Registration Dates
First Submitted
June 17, 2012
First Submitted That Met QC Criteria
June 21, 2012
First Posted (Estimate)
June 22, 2012
Study Record Updates
Last Update Posted (Estimate)
June 22, 2012
Last Update Submitted That Met QC Criteria
June 21, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0033-12-HYMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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