NT-proBNP as a Tool for the Detection of Acute Pulmonary... | NCT01633671

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

NCT01633671

Sponsor

University of Ulm

Status

Completed

Last Update Posted

Jul 6, 2012Estimated

Enrollment

44Actual

Phase

Not provided

Conditions

Pulmonary Embolism
Pulmonary Embolism Without Mention of Acute Cor Pulmonale

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jun 28, 2012

First Submission Date that Met QC Criteria

Jun 29, 2012

First Posted Date

Jul 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2012

Last Update Posted Date

Jul 6, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claus-Martin Muth, Claus-Martin Muth, MD, PhD - Head of the Department of Emergency Medicine, University of UlmPrincipal Investigator

Lead Sponsor

University of UlmOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Suspected APE		Post-surgical patients with clinically suspected acute pulmonary embolism

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acute pulmonary embolism: CT-proof yes vs. no		1 hour after onset of clinical symptoms

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients referred to the ICU with suspected APE

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients after major surgery referred to the anesthesiologic ICU due to suspected acute pulmonary embolism.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claus M Muth, MD	Dept. of Anesthesiology, Div. of Emergency medicine, University hospital Ulm, 89075 Ulm, Germany	Study Chair
Bernd E Winkler, MD	Dept. of Anesthesiology, University hospital Ulm, 89075 Ulm, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Ulm, Michelsberg anaesthesiologic ICU		Ulm	Baden-Wurttemberg	89075	Germany

Condition Browse Module

MeSH Terms

ID	Term
D011655	Pulmonary Embolism

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism
D016769	Embolism and Thrombosis

Browse Leaves

Not provided

Browse Branches

Not provided