Biomarkers in Thoracic Aorta Surgery

Not Applicable

Completed

• Conditions: Aortic Aneurysm; Aortic Dissection; Thoracoabdominal Aneurysm; Complication
• Interventions: Diagnostic Test: blood sample tests for determination of biomarkers levels

• Registration Number: NCT04689139
• Lead Sponsor: Petrovsky National Research Centre of Surgery

Brief 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.

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 Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-25
• Study First Posted: 2020-12-30
• Study Start: 2021-03-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-05-01
• Results First Submitted: 2023-11-23
• Results First Submitted QC: 2023-11-23
• Results First Posted: 2024-05-06
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Elective thoracic and thoracoabdominal surgery

Exclusion Criteria

• Hemolysis in blood sample

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thoracic aorta surgery patients	blood sample tests for determination of biomarkers levels	Blood samples on proadrenomedullin, presepsin, NT-proBNP, Troponin I, procalcitonin are acquired

Primary Outcome Measures

Name	Time	Method
Number of Total Postoperative Complications	up to 10 days	Value reported in the Outcome Measure data table reflects the Number of Total Postoperative Complications across all participants.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Petrovsky Research National Centre of Surgery ( Petrovsky NRCS); 🇷🇺 Moscow, Russian Federation