Extremity Orthopedic SurgeryNCT02394288
Perioperative Cardiac Troponin Levels in Healthy Adults
An observational study of Extremity Orthopedic Surgery, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This study will determine the extent of high-sensitivity cardiac troponin (hs-cTn) release in patients without cardiac risk factors undergoing extremity orthopedic surgery. This study will provide important evidence on how to interpret postoperative cardiac troponin elevations. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Extremity Orthopedic Surgery
- What is being tested?
- Extremity orthopedic or trauma surgery
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2015to Mar 2016
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients undergoing extremity surgery without history of cardiovascular disease
Who may be able to join
- Age 18-35 years
- Extremity orthopedic or trauma surgery: leg, hip, arm, shoulder.
- Planned overnight hospital admission
- No cardiac risk factors (Lee's Revised Cardiac Risk Index Class 1)
- American Society of Anesthesiologists (ASA) physical status I-II
Who cannot join
- Any history or symptoms of cardiac disease
- Kidney or liver disease
- Recent or current trauma to the trunk or head
- Persons with increased vulnerability (e.g. cognitive limitations, prisoners,…)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Division of General Anaesthesia and Intensive Care Medicine, Medical University of Vienna
Vienna, 1090
About this study
Official title: Perioperative High-sensitivity Cardiac Troponin Levels in Healthy Adults Undergoing Elective Trauma Surgery
This study will determine the extent of high-sensitivity cardiac troponin (hs-cTn) release in patients without cardiac risk factors undergoing extremity orthopedic surgery. This study will provide important evidence on how to interpret postoperative cardiac troponin elevations.
- Conditions
- Extremity Orthopedic Surgery
- Being tested
- Extremity orthopedic or trauma surgery
- Keywords
- Cardiac Troponin, Perioperative Period, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extremity orthopedic or trauma surgeryProcedure or surgery
hip, leg, shoulder, arm
| Study group | Role | What they receive |
|---|---|---|
| Adults without cardiac disease | Extremity orthopedic or trauma surgery Receives: Procedure: Extremity orthopedic or trauma surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative change of high-sensitivity cardiac troponin plasma level
3 samples:
- Preoperative,
- POD 0, and
- POD 1
Measured: 24 hours preoperatively to postoperative day (POD) 1
Secondary outcomes (2)
Peak high-sensitivity cardiac troponin plasma level
3 samples:
- Preoperative,
- POD 0, and
- POD 1
Measured: 24 hours preoperatively to POD 1
Incidence rate of high-sensitivity cardiac troponin plasma level elevation
3 samples:
- Preoperative,
- POD 0, and
- POD 1
Measured: 24 hours preoperatively to POD 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extremity Orthopedic SurgeryStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Principal investigator, Andreas Duma, Medical University of Vienna
- Investigators
- Andreas Duma, MD, MSc, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394288
- Sponsor's protocol ID
- 1579/2014
- Status last verified
- Mar 2016
- First submitted
- 13 Mar 2015
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Duma A, Wagner C, Titz M, Maleczek M, Hupfl M, Weihs VB, Samaha E, Herkner H, Szekeres T, Mittlboeck M, Scott MG, Jaffe AS, Nagele P. High-sensitivity cardiac troponin T in young, healthy adults undergoing non-cardiac surgery. Br J Anaesth. 2018 Feb;120(2):291-298. doi: 10.1016/j.bja.2017.09.001. Epub 2017 Dec 5.
PubMed 29406178
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative High-sensitivity Cardiac Troponin Levels in Healthy Adults Undergoing Elective Trauma Surgery
- ClinicalTrials.gov ID
- NCT02394288
- Acronym / sponsor ID
- 1579/2014
- Conditions
- Extremity Orthopedic Surgery
- Keywords
- Cardiac Troponin, Perioperative Period, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Mar 2015 (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.
This study will determine the extent of high-sensitivity cardiac troponin (hs-cTn) release in patients without cardiac risk factors undergoing extremity orthopedic surgery. This study will provide important evidence on how to interpret postoperative cardiac troponin elevations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults without cardiac disease | – | Procedure: Extremity orthopedic or trauma surgeryExtremity orthopedic or trauma surgery |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients undergoing extremity surgery without history of cardiovascular disease
Key inclusion criteria (5 listed)
- Age 18-35 years
- Extremity orthopedic or trauma surgery: leg, hip, arm, shoulder.
- Planned overnight hospital admission
- No cardiac risk factors (Lee's Revised Cardiac Risk Index Class 1)
- American Society of Anesthesiologists (ASA) physical status I-II
Key exclusion criteria (5 listed)
- Any history or symptoms of cardiac disease
- Kidney or liver disease
- Recent or current trauma to the trunk or head
- Persons with increased vulnerability (e.g. cognitive limitations, prisoners,…)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extremity orthopedic or trauma surgeryhip, leg, shoulder, arm | Procedure or surgery | Adults without cardiac disease |
Primary outcome
Perioperative change of high-sensitivity cardiac troponin plasma level
Time frame: 24 hours preoperatively to postoperative day (POD) 1
3 samples: 1. Preoperative, 2. POD 0, and 3. POD 1
2 secondary outcomes
Peak high-sensitivity cardiac troponin plasma level
Time frame: 24 hours preoperatively to POD 1
Incidence rate of high-sensitivity cardiac troponin plasma level elevation
Time frame: 24 hours preoperatively to POD 1
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 21 Mar 2016.
- Derived from this study: PubMed 29406178Duma A, Wagner C, Titz M, Maleczek M, Hupfl M, Weihs VB, Samaha E, Herkner H, Szekeres T, Mittlboeck M, Scott MG, Jaffe AS, Nagele P. High-sensitivity cardiac troponin T in young, healthy adults undergoing non-cardiac surgery. Br J Anaesth. 2018 Feb;120(2):291-298. doi: 10.1016/j.bja.2017.09.001. Epub 2017 Dec 5.
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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.
Andreas Duma, MD, MSc principal investigator
Medical University of Vienna
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 Extremity Orthopedic Surgery, run by Medical University of Vienna at 1 site in Austria.
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 5 inclusion and 5 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 21 Mar 2016. 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 Austria. 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?
Perioperative change of high-sensitivity cardiac troponin plasma level (time frame: 24 hours preoperatively to postoperative day (POD) 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02394288, which also lists 1 linked publication.
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 21 Mar 2016.