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

NCT ID: NCT01626521

Last Updated: 2012-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Pulmonary Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD Exacerbation

Patients admitted to hospital with COPD exacerbation

CT pulmonary angio, blood tests

Intervention Type OTHER

CT pulmonary angiography to determine PE and laboratory blood tests to determine prothrombin fragments F1+2 in blood of COPD patients

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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Ihab Abdelhai, MD

Role: CONTACT

972-4-630-4525

Other Identifiers

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0033-12-HYMC

Identifier Type: -

Identifier Source: org_study_id

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