Pulmonary EmbolismNCT01633671
NT-proBNP as a Tool for the Detection of Acute Pulmonary Artery Embolism (APE)
An observational study of Pulmonary Embolism and Pulmonary Embolism Without Mention of Acute Cor Pulmonale, run by University of Ulm at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Embolism, Pulmonary Embolism Without Mention of Acute Cor Pulmonale
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2008to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients after major surgery referred to the anesthesiologic ICU due to suspected acute pulmonary embolism.
Who may be able to join
- all patients referred to the ICU with suspected APE
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Ulm, Michelsberg anaesthesiologic ICU
Ulm, Baden-Wurttemberg, 89075
About this study
Official title: NT-proBNP: a Useful Tool for the Detection of Acute Pulmonary Artery Embolism in Post-surgical Patients
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.
Read the 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.
- Keywords
- Misadventures to Patients During Surgical and Medical Care, Pulmonary Embolism Without Acute Cor Pulmonale, Pulmonary Embolism Without Mention of Acute Cor Pulmonale
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Suspected APE | Post-surgical patients with clinically suspected acute pulmonary embolism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute pulmonary embolism: CT-proof yes vs. no
Measured: 1 hour after onset of clinical symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startNov 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claus-Martin Muth, University of Ulm
- Investigators
- Claus M Muth, MD, Study chair, Dept. of Anesthesiology, Div. of Emergency medicine, University hospital Ulm, 89075 Ulm, GermanyBernd E Winkler, MD, Principal investigator, Dept. of Anesthesiology, University hospital Ulm, 89075 Ulm, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633671
- Sponsor's protocol ID
- ana-ulm-ntprobnp-288/11
- Status last verified
- Jul 2012
- First submitted
- 28 Jun 2012
- Last updated
- 6 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NT-proBNP: a Useful Tool for the Detection of Acute Pulmonary Artery Embolism in Post-surgical Patients
- ClinicalTrials.gov ID
- NCT01633671
- Acronym / sponsor ID
- ana-ulm-ntprobnp-288/11
- Keywords
- Misadventures to Patients During Surgical and Medical Care, Pulmonary Embolism Without Acute Cor Pulmonale, Pulmonary Embolism Without Mention of Acute Cor Pulmonale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected APE | – | –Post-surgical patients with clinically suspected acute pulmonary embolism |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients after major surgery referred to the anesthesiologic ICU due to suspected acute pulmonary embolism.
Key inclusion criteria (1 listed)
- all patients referred to the ICU with suspected APE
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute pulmonary embolism: CT-proof yes vs. no
Time frame: 1 hour after onset of clinical symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus M Muth, MD study chair
Dept. of Anesthesiology, Div. of Emergency medicine, University hospital Ulm, 89075 Ulm, Germany
Bernd E Winkler, MD principal investigator
Dept. of Anesthesiology, University hospital Ulm, 89075 Ulm, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism and Pulmonary Embolism Without Mention of Acute Cor Pulmonale, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute pulmonary embolism: CT-proof yes vs. no (time frame: 1 hour after onset of clinical symptoms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2012.