Without Cerebral perfusıon Under Deep Hypothermic Circulatory Arrest (DHCA) (18 Deegres) the Comparison of the Undergoing Proximal Aortic Surgery Patients Preoperative and Postoperative Diffusion Magnetic Resonance Imaging's and Neuron Specific Enolase Enzyms Levels. (NON)

Without Cerebral perfusıon Under Deep Hypothermic Circulatory Arrest (DHCA) (18 Deegres) the Comparison of the Undergoing Proximal Aortic Surgery Patients Preoperative and Postoperative Diffusion Magnetic Resonance Imaging's and Neuron Specific Enolase Enzyms Levels

Deep hypothermic circulatory arrest (DHCA) (18 degree) without cerebral perfusion is a safe technique. Resarchers use this technique in patients with proximal aortic pathologies.

During the DHCA period, cerebral silent ischemic events may occur. But the silent ischemic events don't neurological problems with patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Cerebral Infarct; Neurological Morbidity; Neurological Complication
• Intervention / Treatment: Procedure: DHCA

Detailed Description

It is important to evaluate neurological functions in patients with ascending aortic and aortic root aneurysms who underwent deep hypothermic circulatory arrest (18 degrees) and did not undergo cerebral perfusion. However, neurological changes that are reflected in the clinic are not always encountered. Using preoperative and postoperative diffusion magnetic resonance imaging, silent ischemic lesions that are not reflected in the clinic can be detected. Although there are studies using DW-MRI in patients undergoing different cerebral protection methods in the literature, there are no studies conducted on patients who underwent deep hypothermic circulatory arrest without cerebral perfusion.

To detect silent ischemic lesions with preoperative and postoperative diffusion magnetic resonance method in patients with ascending aortic and aortic root aneurysms undergoing deep hypothermic circulatory arrest (18 degrees) and without cerebral perfusion, and to investigate the correlation between preoperative and postoperative neuron-specific enolase levels and serbral findings.

Cerebral ischemic lesions that may occur in patients undergoing deep hypothermic circulatory arrest (18 degrees) and undergoing ascending aortic and aortic root aneurysm surgery without cerebral perfusion will be detected, and the clinical follow-up and treatment of the patients will be better managed.

We base the imaging of diffusion MR among the examinations to be performed on literature studies that show that withdrawal of patients in the early postoperative period (3rd-7th days) due to the surgical method to be performed without cerebral perfusion under deep hypothermic circulatory arrest, increases the specificity and sensitivity of the test. Therefore, the application of diffusion MR imaging in the early postoperative period (3rd-7th days) after a surgical technique performed under deep hypothermic circulatory arrest (18 degrees) without cerebral perfusion constitutes an indication for diffusion MR in order to detect cerebral ischemic lesions in the early period. Therefore, diffusion MR imaging to be taken in the early period (3rd-7th days) will provide us with the opportunity to create an effective algorithm in terms of patient treatment and follow-up.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Burak Bozkurt, M.D; Phone Number: (+90)5541626795; Email: drburakbozkurtt@gmail.com

Study Locations

• Turkey
  • Üsküdar/ Selimiye
    • Istanbul, Üsküdar/ Selimiye, Turkey, 34668
      • Dr. Siyami Ersek Thoracic And Cardiovascular Surgery Training And Research Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with ascending aorta and aortic root aneurysm.
• 18-85 years old

Exclusion Criteria:

• Patients without ascending aortic and aortic root aneurysms
• outside the age range of 18-85, emergency surgery,
• Exceeding the magnetic resonance imaging extraction time limit.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: undergoing deep hypothermic cırculatory arrest patients; Difüsıon magnetic rezonans imaging , neuron spesific enolase enzym level , deep hypotermic cırculatory arrest	Procedure: DHCA; DHCA THE USE OF SEREBRAL PROTECTİON TECHNİQUE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring postoperative changes in cranial diffusion MR imaging.	Changes due to new ischemia or hypoperfusion in the cerebral and cerebellar hemispheres will be measured in terms of volume(cm square or mm square). The measurements will be determined using cranial diffusion mr.	Preoperative (1-3 days before operation time) and postoperative (until the 7th day) cranial diffusion MR of the patients will be taken and compared

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the comparison of the preoperative and postoperative neuron spesific enolase enzyms level.	The neuron-specific enolase levels of the patients will be checked in the morning of the operation and postoperatively (until 6-36 hours). Neuron-specific enolase enzyme levels will be measured from the blood sample.	The neuron-specific enolase levels of the patients will be checked in the morning of the operation and postoperatively (up to 6-36 hours).

Collaborators and Investigators

• Sponsor: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
• Investigators: Principal Investigator: Mehmet Kaplan, Prof. Dr, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2020
• Primary Completion (Actual): January 1, 2024
• Study Completion (Estimated): December 10, 2025

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Stroke; Brain Infarction; Cerebral Infarction
• Other Study ID Numbers: 2020/KK / 239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: starting 6 months after publication).
• IPD Sharing Time Frame: starting 6 months after publication).
• IPD Sharing Access Criteria: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

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