Biomarkers in Thoracic Aorta Surgery

June 20, 2024 updated by: Petrovsky National Research Centre of Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Elective thoracic and thoracoabdominal surgery

Exclusion Criteria:

  • Hemolysis in blood sample

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Using of proadrenomedullin, presepsin, NT-proBNP, Troponin I to determine the correlation of perioperative complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Total Postoperative Complications
Time Frame: up to 10 days
Total amount of various postoperative complications
up to 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Number Affected by All-Cause Mortality
Time Frame: up to 10 days
Overall number of participants, in each arm/group, who died due to any cause
up to 10 days
Number of Participants Who Require Extracorporeal Detoxication
Time Frame: up to 10 days
up to 10 days
Number of Cardiac Disorders
Time Frame: up to 10 days
Number of patients who needed medicamental cardiotonic support more than 1 day
up to 10 days
Number of Vascular Disorders
Time Frame: up to 10 days
Number of patients who needed vasopressor support more than 1 day
up to 10 days
Number of Infections and Infestations
Time Frame: up to 10 days
Number of patients who develop systemic infection and/or operation wound infection
up to 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Petrovsky National Research Centre of Surgery

Investigators

  • Study Director: Boris Akselrod, Professor, Petrovsky NRCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

December 25, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

July 17, 2024

Last Update Submitted That Met QC Criteria

June 20, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 039420200002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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