Evaluation of Cerebral Parenchymal Changes in Patients Undergoing Proximal Aortic Surgery With Deep Hypothermic Circulatory Arrest Using Diffusion MRI

NCT04755439 | Completed

• 1 other identifier: 2020/KK / 239
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Infarct; Neurological Morbidity; Neurological Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 (up to 6-36 hours).

Study Arms (1)

undergoing deep hypothermic cırculatory arrest patients

OTHER

Difüsıon magnetic rezonans imaging , neuron spesific enolase enzym level , deep hypotermic cırculatory arrest

Procedure: DHCA

Interventions

DHCA PROCEDURE

DHCA THE USE OF SEREBRAL PROTECTİON TECHNİQUE

undergoing deep hypothermic cırculatory arrest patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital: lead

Study Sites (1)

Dr. Siyami Ersek Thoracic And Cardiovascular Surgery Training And Research Hospital.

Istanbul, Üsküdar/ Selimiye, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Infarction

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Mehmet Kaplan, Prof. Dr

  Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: non
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,

Model Details: Single center prospective clinical research

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 16, 2021
• Study Start: December 10, 2020
• Primary Completion: January 1, 2024
• Study Completion: January 30, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication).
• Access Criteria: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code

Locations

TU (1)