NCT04689139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
2 years until next milestone

Results Posted

Study results publicly available

May 6, 2024

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

December 22, 2020

Results QC Date

November 23, 2023

Last Update Submit

August 23, 2024

Conditions

Outcome Measures

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.

    up to 10 days

Secondary Outcomes (5)

  • Total Number Affected by All-Cause Mortality

    up to 10 days

  • Number of Participants Who Require Extracorporeal Detoxication

    up to 10 days

  • Number of Cardiac Disorders

    up to 10 days

  • Number of Vascular Disorders

    up to 10 days

  • Number of Infections and Infestations

    up to 10 days

Study Arms (1)

Thoracic aorta surgery patients

EXPERIMENTAL

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

Diagnostic Test: blood sample tests for determination of biomarkers levels

Interventions

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

Thoracic aorta surgery patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective thoracic and thoracoabdominal surgery

You may not qualify if:

  • Hemolysis in blood sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Petrovsky Research National Centre of Surgery ( Petrovsky NRCS)

Moscow, 119991, Russia

Location

Related Links

MeSH Terms

Conditions

Aortic AneurysmAortic Dissection

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesDissection, Blood VesselAcute Aortic Syndrome

Results Point of Contact

Title
Dr. Artem Gubko
Organization
Petrovsky NRCS

Study Officials

  • Boris Akselrod, Professor

    Petrovsky NRCS

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2020

First Posted

December 30, 2020

Study Start

March 1, 2021

Primary Completion

February 1, 2022

Study Completion

May 1, 2022

Last Updated

September 19, 2024

Results First Posted

May 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations