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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 7 November 2016
Main ID:  NCT02697786
Date of registration: 25/01/2016
Prospective Registration: No
Primary sponsor: Marija Bozhinovska
Public title: Neuromonitoring in Patients During Aortic Valve Replacement IMLPBIAVR
Scientific title: The Impact of Intraoperative Microemboli Load on Postoperative Brain Injury in Patients Undergoing Aortic Valve Replacement Preformed With Two Different Surgical Approaches
Date of first enrolment: January 2016
Target sample size: 60
Recruitment status: Enrolling by invitation
URL:  https://clinicaltrials.gov/show/NCT02697786
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention  
Phase:  Phase 3
Countries of recruitment
Slovenia
Contacts
Name:     Borut Gersak, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  University Medical Centre Ljubljana
Name:     Marija Bozhinovska, MD, MSc
Address: 
Telephone:
Email:
Affiliation:  University Medical Centre Ljubljana
Name:     Matej Podbregar, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  University Medical Centre Ljubljana
Name:     Maja Sostaric, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  University Medical Centre Ljubljana
Name:     Tomislav Klokocovnik, MD,PhD
Address: 
Telephone:
Email:
Affiliation:  University Medical Centre Ljubljana
Key inclusion & exclusion criteria

Inclusion Criteria:

- Isolated aortic valve stenosis as well as asymptomatic patients with depressed
systolic function

- Symptomatic patients with normal or depressed left ventricular function

- Patients with American Society of Anesthesiologist (ASA) physical status
classification 2 or 3

Exclusion Criteria:

- History of brain stroke

- EF less than 20%

- History of alcohol abuse

- Epilepsy of history of psychiatric illness and antipsychotic drugs

- Patients with stenosis on carotid arteries

- Patients with preformed surgery or already stented carotid arteries

- Patients with poor or absent acoustic temporal window

- Diagnosed dementia



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Brain Injury
Intervention(s)
Device: Transcranial doppler
Primary Outcome(s)
Detection of S100B serum protein, marker of brain tissue damage [Time Frame: Before induction of anesthesia, 6 h , 24 h, 48h and 7 days after CPB]
Detection of serum interleukin IL-1, IL-6,IL-8,Il-10 and Microparticles [Time Frame: Before induction of anesthesia, 6 h , 24 h, 48h and 7 days after CPB]
Detection of the intraoperative microembolic signals during minimal invasive sternotomy compared to full sternotomy with TCD during aortic valve surgery [Time Frame: Intraoperative detection:Beginning of surgery, after sternotomy, during aortic cannulation, during CPB, during de-aeration, opening of the clamp on the aorta and after CBP removal before chest closure.]
Secondary Outcome(s)
Assessment of cerebrovascular reactivity using visually evoked cerebral blood flow velocity response (VEFR) measurements [Time Frame: 7 days before and 7 days after surgery]
Assessment of neurologic and cognitive function in patients undergoing AVR [Time Frame: 7 days before and 7 days after surgery]
Secondary ID(s)
ARRS-RPROJ - J R- 2014- 191
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Slovenian Research Agency
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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