Aortic AneurysmNCT04689139
Biomarkers in Thoracic Aorta Surgery
A study testing blood sample tests for determination of biomarkers levels in people with Aortic Aneurysm and Thoracoabdominal Aneurysm, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
Trial summary
Biomarkers can play a vital role in prognosing the perioperative complications in thoracic aorta surgery. The goal of a study is to determine the correlation between intraoperative level of certain biomarkers and total amount of peroperative complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Aortic Aneurysm, Thoracoabdominal Aneurysm, Aortic Dissection
- What is being tested?
- blood sample tests for determination of biomarkers levels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective thoracic and thoracoabdominal surgery
Who cannot join
- Hemolysis in blood sample
Trial locations and contacts
1 site in 1 country.
Russia1 site
Petrovsky Research National Centre of Surgery ( Petrovsky NRCS)
Moscow, 119991
About this study
Official title: Role of Intraoperative Biomarkers in Prognosis of Perioperative Complications in Reconstructive Thoracic Aorta Surgery
Biomarkers can play a vital role in prognosing the perioperative complications in thoracic aorta surgery. The goal of a study is to determine the correlation between intraoperative level of certain biomarkers and total amount of peroperative complications.
Read the detailed description
This study aims to assess the association between levels of biomarkers and postoperative complications in patients after thoracic and thoracoabdominal aortic reconstruction.
- Being tested
- blood sample tests for determination of biomarkers levels
- Medical subject headings
- Aortic Aneurysm, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample tests for determination of biomarkers levelsDiagnostic test
Using of proadrenomedullin, presepsin, NT-proBNP, Troponin I to determine the correlation of perioperative complications.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic aorta surgery patients | Experimental | Blood samples on proadrenomedullin, presepsin, NT-proBNP, Troponin I, procalcitonin are acquired Receives: Diagnostic Test: blood sample tests for determination of biomarkers levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Total Postoperative Complications
Value reported in the Outcome Measure data table reflects the Number of Total Postoperative Complications across all participants.
Measured: up to 10 days
Secondary outcomes (5)
Total Number Affected by All-Cause Mortality
Overall number of participants, in each arm/group, who died due to any cause
Measured: up to 10 days
Number of Participants Who Require Extracorporeal Detoxication
Measured: up to 10 days
Number of Cardiac Disorders
Number of patients who needed medicamental cardiotonic support more than 1 day
Measured: up to 10 days
Number of Vascular Disorders
Number of patients who needed vasopressor support more than 1 day
Measured: up to 10 days
Number of Infections and Infestations
Number of patients who develop systemic infection and/or operation wound infection
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Mar 2021
- Primary completion1 Feb 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aortic AneurysmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petrovsky National Research Centre of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris Akselrod, Professor, Study director, Petrovsky NRCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689139
- Sponsor's protocol ID
- 039420200002
- Status last verified
- Aug 2024
- First submitted
- 22 Dec 2020
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Intraoperative Biomarkers in Prognosis of Perioperative Complications in Reconstructive Thoracic Aorta Surgery
- ClinicalTrials.gov ID
- NCT04689139
- Acronym / sponsor ID
- 039420200002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Petrovsky National Research Centre of SurgeryUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Posted 6 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Biomarkers can play a vital role in prognosing the perioperative complications in thoracic aorta surgery. The goal of a study is to determine the correlation between intraoperative level of certain biomarkers and total amount of peroperative complications.
Detailed description
This study aims to assess the association between levels of biomarkers and postoperative complications in patients after thoracic and thoracoabdominal aortic reconstruction.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic aorta surgery patients | Experimental | Diagnostic Test: blood sample tests for determination of biomarkers levelsBlood samples on proadrenomedullin, presepsin, NT-proBNP, Troponin I, procalcitonin are acquired |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective thoracic and thoracoabdominal surgery
Key exclusion criteria (1 listed)
- Hemolysis in blood sample
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 |
|---|---|---|
| blood sample tests for determination of biomarkers levelsUsing of proadrenomedullin, presepsin, NT-proBNP, Troponin I to determine the correlation of perioperative complications. | Diagnostic test | Thoracic aorta surgery patients |
Primary outcome
Number of Total Postoperative Complications
Time frame: up to 10 days
Value reported in the Outcome Measure data table reflects the Number of Total Postoperative Complications across all participants.
5 secondary outcomes
Total Number Affected by All-Cause Mortality
Time frame: up to 10 days
Number of Participants Who Require Extracorporeal Detoxication
Time frame: up to 10 days
Number of Cardiac Disorders
Time frame: up to 10 days
Number of Vascular Disorders
Time frame: up to 10 days
Number of Infections and Infestations
Time frame: up to 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Assessing the significance of some biomarkers in perioperative period after thoracic aortic reconstructionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Boris Akselrod, Professor study director
Petrovsky NRCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample tests for determination of biomarkers levels in people with Aortic Aneurysm and Thoracoabdominal Aneurysm, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
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 19 Sep 2024. 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 Russia. 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?
Yes. Results are posted in the registry (first posted 6 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Total Postoperative Complications (time frame: up to 10 days). 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 19 Sep 2024.