CClinicalTrials.gg
CompletedNCT04689139Updated Sep 19, 2024Results posted

Biomarkers in Thoracic Aorta Surgery

An interventional study of blood sample tests for determination of biomarkers levels in Aortic Aneurysm, Thoracoabdominal Aneurysm and Aortic Dissection, sponsored by Petrovsky National Research Centre of Surgery. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Petrovsky National Research Centre of Surgery · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Aortic Aneurysm
  • Thoracoabdominal Aneurysm
  • Aortic Dissection
  • Complication
03

In context

Aneurysm

960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.

This study's enrollment of 132 is above the median of 72 across 462 interventional studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

Petrovsky National Research Centre of Surgery is the lead sponsor of 18 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Elective thoracic and thoracoabdominal surgery

Exclusion criteria

Exclusion Criteria:

  • Hemolysis in blood sample
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
132 participants (actual)

Study arms

  • Experimental
    Thoracic aorta surgery patients

    Blood samples on proadrenomedullin, presepsin, NT-proBNP, Troponin I, procalcitonin are acquired

    Diagnostic Test: blood sample tests for determination of biomarkers levels

Interventions

  • Diagnostic testblood sample tests for determination of biomarkers levels

    Using of proadrenomedullin, presepsin, NT-proBNP, Troponin I to determine the correlation of perioperative complications.

06

What researchers measure

Primary outcomes

  1. Number of Total Postoperative Complications

    Value reported in the Outcome Measure data table reflects the Number of Total Postoperative Complications across all participants.

    Time frame: up to 10 days

Secondary outcomes

  1. Total Number Affected by All-Cause Mortality

    Overall number of participants, in each arm/group, who died due to any cause

    Time frame: up to 10 days

  2. Number of Participants Who Require Extracorporeal Detoxication

    Time frame: up to 10 days

  3. Number of Cardiac Disorders

    Number of patients who needed medicamental cardiotonic support more than 1 day

    Time frame: up to 10 days

  4. Number of Vascular Disorders

    Number of patients who needed vasopressor support more than 1 day

    Time frame: up to 10 days

  5. Number of Infections and Infestations

    Number of patients who develop systemic infection and/or operation wound infection

    Time frame: up to 10 days

07

Results

Posted May 6, 2024

Participant flow

Participant flow — Overall Study
MilestoneThoracic Aorta Surgery Patients
Started132
Completed132
Not completed0

Outcome measures

PrimaryNumber of Total Postoperative Complications

Value reported in the Outcome Measure data table reflects the Number of Total Postoperative Complications across all participants.

Time frame:
up to 10 days
Reported as:
Number · post-operative complications
Number of Total Postoperative Complications
post-operative complicationsThoracic Aorta Surgery Patients
Number of Total Postoperative Complications69
SecondaryTotal Number Affected by All-Cause Mortality

Overall number of participants, in each arm/group, who died due to any cause

Time frame:
up to 10 days
Reported as:
Count of participants · Participants
Total Number Affected by All-Cause Mortality
ParticipantsThoracic Aorta Surgery Patients
Total Number Affected by All-Cause Mortality2
SecondaryNumber of Participants Who Require Extracorporeal Detoxication
Time frame:
up to 10 days
Reported as:
Count of participants · Participants
Number of Participants Who Require Extracorporeal Detoxication
ParticipantsThoracic Aorta Surgery Patients
Number of Participants Who Require Extracorporeal Detoxication7
SecondaryNumber of Cardiac Disorders

Number of patients who needed medicamental cardiotonic support more than 1 day

Time frame:
up to 10 days
Reported as:
Count of participants · Participants
Number of Cardiac Disorders
ParticipantsThoracic Aorta Surgery Patients
Number of Cardiac Disorders16
SecondaryNumber of Vascular Disorders

Number of patients who needed vasopressor support more than 1 day

Time frame:
up to 10 days
Reported as:
Count of participants · Participants
Number of Vascular Disorders
ParticipantsThoracic Aorta Surgery Patients
Number of Vascular Disorders14
SecondaryNumber of Infections and Infestations

Number of patients who develop systemic infection and/or operation wound infection

Time frame:
up to 10 days
Reported as:
Count of participants · Participants
Number of Infections and Infestations
ParticipantsThoracic Aorta Surgery Patients
Number of Infections and Infestations36

Adverse events

Collected over Up to 10 days postoperative. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Thoracic Aorta Surgery Patients2/132 (1.5%)41/132 (31.1%)24/132 (18.2%)
Most frequent serious events
Most frequent serious events
EventThoracic Aorta Surgery Patients
PneumoniaInfections and infestations29/132
Patients requiring extracorporeal detoxicationRenal and urinary disorders7/132
Myocardial infarctionCardiac disorders5/132
Most frequent other events
Most frequent other events
EventThoracic Aorta Surgery Patients
Cardiac dysrhythmiasCardiac disorders24/132

Baseline characteristics

Age, Continuous
Age, Continuous(years)Thoracic Aorta Surgery Patients
Mean56 ± 13
Sex: Female, Male
Sex: Female, Male(Participants)Thoracic Aorta Surgery Patients
Female45
Male87
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Thoracic Aorta Surgery Patients
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White132
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Thoracic Aorta Surgery Patients
Russia132
Body surface area, м²
Body surface area, м²(square meters)Thoracic Aorta Surgery Patients
Mean2 ± 0.22
08

Study locations

1 site
  • Petrovsky Research National Centre of Surgery ( Petrovsky NRCS)
    Moscow, 119991, Russian Federation
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Dec 22, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04689139
Lead sponsor
Petrovsky National Research Centre of Surgery
Responsible party
Sponsor
First posted
Dec 30, 2020
Start date
Mar 1, 2021
Primary completion
Feb 1, 2022
Completion
May 1, 2022
Results posted
May 6, 2024
Last update
Sep 19, 2024

Study contacts

Boris Akselrod, Professor
study director · Petrovsky NRCS

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion