Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03540433




Registration number
NCT03540433
Ethics application status
Date submitted
17/05/2018
Date registered
30/05/2018
Date last updated
13/03/2024

Titles & IDs
Public title
International Observational Study on Perioperative Cognitive Trajectories (POCD Census International/PCI)
Scientific title
Evaluation of POCD-Census Prospective, International Observation Study
Secondary ID [1] 0 0
PCI
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Cognitive Deficit (POCD) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Surgical patients at Campus Virchow- Klinikum and Campus Charité Mitte
* Aged = 70 years
* Informed consent
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Manifest dementia
* Lack of willingness to store and disseminate pseudonymized disease data as part of the clinical trial
* Lack of readiness to participate in the follow-up examinations and contact to make an appointment
* Placement in an institute under judicial or official orders (according to German drug Law §40 (1) 4)
* Persons without a permanent residence or other circumstances that call into question the availability by telephone or post for postoperative examination
* Employees of the respective study centers
* illiteracy
* Patients with a neuropsychiatric condition that limits the performance of neurocognitive testing
* Patients with hearing and / or vision problems that limit the performance of neuro-cognitive testing
* Simultaneous participation in a prospective clinical intervention study (apart from the desired parallel participation in the anaesthesiological study Praep-Go, EA1/225/19)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
173
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
Charite University, Berlin, Germany
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Claudia Spies, MD, Prof.
Address 0 0
Charite University, Berlin, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Claudia Spies, MD, Prof.
Address 0 0
Country 0 0
Phone 0 0
+49 30 450 55 11 02
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03540433