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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Claus-Martin Muth, University of Ulm

ClinicalTrials.gov Identifier:

NCT01633671

First received: June 28, 2012

Last updated: July 4, 2012

Last verified: July 2012

History of Changes

Purpose

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
Pulmonary Embolism Pulmonary Embolism Without Mention of Acute Cor Pulmonale


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Pulmonary Embolism

U.S. FDA Resources

Further study details as provided by University of Ulm:

Primary Outcome Measures:

Acute pulmonary embolism: CT-proof yes vs. no [ Time Frame: 1 hour after onset of clinical symptoms ] [ Designated as safety issue: No ]


Enrollment:	44
Study Start Date:	November 2008
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
Suspected APE Post-surgical patients with clinically suspected acute pulmonary embolism

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.

Eligibility


Genders Eligible for Study:	Both
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:

none

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: 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

No publications provided


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
Study First Received:	June 28, 2012
Last Updated:	July 4, 2012
Health Authority:	Germany: Ethics Commission

Keywords provided by 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 Cardiovascular Diseases Embolism and Thrombosis	Lung Diseases Respiratory Tract Diseases Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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