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CITADEL: a study to asess the effectiveness of CITicoline (TRAUSAN) in preventing cognitive decline After DELirium in older adults with proximal hip fracture
EU CTIS ID: 2025-522306-21-00
What this study is testing
The primary aim of this study is to assess potential differences in cognitive profiles 6 months post-randomization among older adults hospitalized for proximal hip fractures with perioperative delirium, comparing the intervention arm (citicoline, TRAUSAN26) to the control arm.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Individuals aged >65 years, who were admitted for a proximal hip fracture to the Orthogeriatric Unit and underwent hip fracture surgery (IRCCS San Gerardo dei Tintori Foundation, Monza)
- Clinical diagnosis of delirium (arising from any cause), ascertained pre- or post-operatively using the 4AT score (cut-off > 4/12)
- Diagnosis of chronic vascular encephalopathy (corroborated by clinical documentation or previous cerebral imaging), i.e. evidence of neurological and cognitive disorder resulting from cerebrovascular accidents
- Prognosis quoad vitam ≥ 3 months
- Availability of a formal or informal caregiver who may help the participant to take the prescribed dose and follow the visit schedule
- Informed consent, freely granted from the participant or from his/her legal guardian (or from an impartial witness in cases where the patient is unable to sign but clearly expresses the will to participate), and acquired before the randomization
You likely can't join if
- Diagnosis of severe dementia (defined by medical clinical records or by the presence of an AD8 score >6 and a Global Deterioration Scale score >6)
- Current therapy with citicoline
- Any contraindications to citicoline (TRAUSAN), including allergy to acetylsalicylic acid or excipients contained in the drug, previous adverse reactions to citicoline, hypertonia of the parasympathetic nervous system, low-sodium diet
- Clinical conditions or situations other than the condition being studied, which in the opinion of the researchers could interfere with the study or not allow optimal participation
- Persistent in-hospital delirium (> 6 days or still present 24 hours prior to discharge).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.