NCT01633671

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
Last Updated

July 6, 2012

Status Verified

July 1, 2012

Enrollment Period

3.1 years

First QC Date

June 28, 2012

Last Update Submit

July 4, 2012

Conditions

Pulmonary EmbolismPulmonary Embolism Without Mention of Acute Cor Pulmonale

Keywords

Misadventures to Patients During Surgical and Medical CarePulmonary Embolism Without Acute Cor PulmonalePulmonary Embolism Without Mention of Acute Cor Pulmonale

Outcome Measures

Primary Outcomes (1)

  • Acute pulmonary embolism: CT-proof yes vs. no

    1 hour after onset of clinical symptoms

Study Arms (1)

Suspected APE

Post-surgical patients with clinically suspected acute pulmonary embolism

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • all patients referred to the ICU with suspected APE

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ulm, Michelsberg anaesthesiologic ICU

Ulm, Baden-Wurttemberg, 89075, Germany

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Claus-Martin Muth, MD, PhD - Head of the Department of Emergency Medicine

Study Record Dates

First Submitted

June 28, 2012

First Posted

July 4, 2012

Study Start

November 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 6, 2012

Record last verified: 2012-07

Locations

DE(1)