Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This study aims to assess the association between levels of biomarkers and postoperative complications in patients after thoracic and thoracoabdominal aortic reconstruction.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracic aorta surgery patients | Experimental | Blood samples on proadrenomedullin, presepsin, NT-proBNP, Troponin I, procalcitonin are acquired |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sample tests for determination of biomarkers levels | Diagnostic Test | Using of proadrenomedullin, presepsin, NT-proBNP, Troponin I to determine the correlation of perioperative complications. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number Affected by All-Cause Mortality | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boris Akselrod, Professor | Petrovsky NRCS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Petrovsky Research National Centre of Surgery ( Petrovsky NRCS) | Moscow | 119991 | Russia |
Not provided
| Label | URL |
|---|---|
| Assessing the significance of some biomarkers in perioperative period after thoracic aortic reconstruction | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Thoracic Aorta Surgery Patients | Blood samples on proadrenomedullin, presepsin, NT-proBNP, Troponin I, procalcitonin are acquired blood sample tests for determination of biomarkers levels: Using of proadrenomedullin, presepsin, NT-proBNP, Troponin I to determine the correlation of perioperative complications. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Thoracic Aorta Surgery Patients | Blood samples on proadrenomedullin, presepsin, NT-proBNP, Troponin I, procalcitonin are acquired blood sample tests for determination of biomarkers levels: Using of proadrenomedullin, presepsin, NT-proBNP, Troponin I to determine the correlation of perioperative complications. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Total Postoperative Complications | Value reported in the Outcome Measure data table reflects the Number of Total Postoperative Complications across all participants. | Posted | Number | post-operative complications | up to 10 days |
|
|
Up to 10 days postoperative
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Thoracic Aorta Surgery Patients | Blood samples on proadrenomedullin, presepsin, NT-proBNP, Troponin I, procalcitonin are acquired blood sample tests for determination of biomarkers levels: Using of proadrenomedullin, presepsin, NT-proBNP, Troponin I to determine the correlation of perioperative complications. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patients requiring extracorporeal detoxication | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac dysrhythmias | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Artem Gubko | Petrovsky NRCS | +79684241490 | gubko@artvig.ru |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2020 | May 15, 2024 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 10 days |
| Number of Cardiac Disorders | Number of patients who needed medicamental cardiotonic support more than 1 day | up to 10 days |
| Number of Vascular Disorders | Number of patients who needed vasopressor support more than 1 day | up to 10 days |
| Number of Infections and Infestations | Number of patients who develop systemic infection and/or operation wound infection | up to 10 days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body surface area, м² | Mean | Standard Deviation | square meters |
|
|
|
| Secondary | Total Number Affected by All-Cause Mortality | Overall number of participants, in each arm/group, who died due to any cause | Posted | Count of Participants | Participants | up to 10 days |
|
|
|
| Secondary | Number of Participants Who Require Extracorporeal Detoxication | Posted | Count of Participants | Participants | up to 10 days |
|
|
|
| Secondary | Number of Cardiac Disorders | Number of patients who needed medicamental cardiotonic support more than 1 day | Posted | Count of Participants | Participants | up to 10 days |
|
|
|
| Secondary | Number of Vascular Disorders | Number of patients who needed vasopressor support more than 1 day | Posted | Count of Participants | Participants | up to 10 days |
|
|
|
| Secondary | Number of Infections and Infestations | Number of patients who develop systemic infection and/or operation wound infection | Posted | Count of Participants | Participants | up to 10 days |
|
|
|
| 2 |
| 132 |
| 41 |
| 132 |
| 24 |
| 132 |
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D000094665 |
| Dissection, Blood Vessel |
| D000094683 | Acute Aortic Syndrome |