Status:
ACTIVE_NOT_RECRUITING
Evaluation of Essential Metal Metabolism
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Disturbance of Consciousness
Alteration of Metabolism
Eligibility:
All Genders
18+ years
Brief Summary
Disturbance of consciousness (DoC) is a state in which consciousness is altered following brain damage and can manifest in several conditions that result from the loss of regulation of the neural func...
Eligibility Criteria
Inclusion
- Patients who have been in a coma state, documented with a GCS ≤ 8 for at least 24 hours;
- Presence of a disturbance of consciousness, identified through the Coma Recovery Scale-revised (CRS-r) and classified as coma, vegetative state or minimally conscious state;
- Latency of the acute event between 15 days and 6 months;
- Ability of the caregiver/guardian to understand and sign the informed consent.
Exclusion
- Age \<18 years;
- Psychiatric or other pathologies;
- Inflammatory state related to ongoing infections;
- Refusal or inability to sign the written informed consent to participate in the study.
Key Trial Info
Start Date :
March 17 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06911515
Start Date
March 17 2025
End Date
March 31 2027
Last Update
April 9 2025
Active Locations (1)
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1
UOC Neuroriabilitazione ad alta intensità , Policlinico "A. Gemelli"
Roma, RM, Italy, 00168