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NT-proBNP as a Tool for the Detection of Acute Pulmonary Artery Embolism (APE)

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ClinicalTrials.gov Identifier: NCT01633671
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : July 6, 2012
Sponsor:
Information provided by (Responsible Party):
Claus-Martin Muth, University of Ulm

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
In patients with suspected APE (Acute Pulmonary Embolism) referred to the intensive care unit (ICU)after major surgery, serum NT-proBNP (N-terminal proBNP), Troponin-I and D-dimers were measured according to the standard hospital protocol. To definitively confirm or exclude APE, all patients underwent an angiographic CT-scan of the thorax.

Condition or disease
Pulmonary Embolism Pulmonary Embolism Without Mention of Acute Cor Pulmonale

Detailed Description:

In patients with suspected APE referred to the intensive care unit after major surgery, serum NT-proBNP, Troponin-I and D-dimers were measured according to the standard hospital protocol. Blood samples were obtained within one hour after the onset of clinical symptoms.

Definitive confirmation or exclusion of APE was performed with an angiographic CT-scan of the thorax.


Study Design
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Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: NT-proBNP: a Useful Tool for the Detection of Acute Pulmonary Artery Embolism in Post-surgical Patients
Study Start Date : November 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

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Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Suspected APE
Post-surgical patients with clinically suspected acute pulmonary embolism


Outcome Measures
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Primary Outcome Measures :
  1. Acute pulmonary embolism: CT-proof yes vs. no [ Time Frame: 1 hour after onset of clinical symptoms ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients after major surgery referred to the anesthesiologic ICU due to suspected acute pulmonary embolism.
Criteria

Inclusion Criteria:

all patients referred to the ICU with suspected APE

Exclusion Criteria:

Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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): NCT01633671


Locations
Germany
University of Ulm, Michelsberg anaesthesiologic ICU
Ulm, Baden-Wuerttemberg, Germany, 89075
Sponsors and Collaborators
University of Ulm
Investigators
Study Chair: Claus M Muth, MD Dept. of Anesthesiology, Div. of Emergency medicine, University hospital Ulm, 89075 Ulm, Germany
Principal Investigator: Bernd E Winkler, MD Dept. of Anesthesiology, University hospital Ulm, 89075 Ulm, Germany
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Claus-Martin Muth, Claus-Martin Muth, MD, PhD - Head of the Department of Emergency Medicine, University of Ulm
ClinicalTrials.gov Identifier: NCT01633671     History of Changes
Other Study ID Numbers: ana-ulm-ntprobnp-288/11
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: July 6, 2012
Last Verified: July 2012

Keywords provided by Claus-Martin Muth, University of Ulm:
Misadventures to Patients During Surgical and Medical Care
Pulmonary Embolism Without Acute Cor Pulmonale
Pulmonary Embolism Without Mention of Acute Cor Pulmonale

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