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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03683537
Other study ID # MKNC 02/2018
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 15, 2018
Est. completion date September 15, 2019

Study information

Verified date June 2019
Source Moscow Clinical Scientific Center
Contact Sergey Kamnev, M.D.
Phone +0079055918462
Email korium1605@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Assessment of serum level of glial fibrillary acidic protein (GFAP) before surgery (on the day of surgery), 24 hours after surgery and on 3 or 4 postoperative day. Neuropsychological testing before surgery and on 3 or 4 day after surgery. Investigation of relationship between changes of GFAP and scores of neuropsychological tests.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date September 15, 2019
Est. primary completion date July 15, 2019
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- Patients with different diseases, who require prolonged laparoscopy or open surgery

- Age more than 60

- ASA I-III

- Informed consent to participate in the study

Exclusion Criteria:

- ASA IV-V

- Severe neurodegenerative or psychological diseases

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Glial fibrillary acidic protein
3 samples of serum are drawn from patients. The 1st Sample of patient serum is drawn before induction into anesthesia. The 2nd is drawn 24 hours after the 1st one. The 3rd sample is drawn on 3 or 4 postoperative day. All samples collected and preserved in the same temperature as required for ELISA.

Locations

Country Name City State
Russian Federation Moscow Clinical Scientific Center Moscow

Sponsors (1)

Lead Sponsor Collaborator
Moscow Clinical Scientific Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in serum GFAP GFAP(3) - GFAP (1); GFAP (2) - GFAP (1) 1 year
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