Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT04335968
Eligibility Criteria:
Inclusion Criteria:
* Demographic criteria: patient 70 years old or older
* Diagnostic criteria: isolated fracture of a lower limb
* Proximal femoral fractures: head, cervical, or trochanteric fractures
* Periprosthetic hip fracture
* Femoral shaft fracture
* Distal femoral fractures: supracondylar or condylar
* Periprosthetic knee fracture
* Tibial plateau fracture
* Treatments/strategies/procedures: scheduled orthopedic surgery (osteosynthesis or arthroplasty)
* proxy or care giver knowing baseline cognitive status of the patient present or reachable by phone for an interview
Exclusion Criteria:
* Patient already taking Melatonin
* Contraindications and precaution for use of Melatonin administration:
* Hypersensitivity to the active substance or to any of the excipients of Circadin©
* Liver failure (presence of some of the following clinical and biological symptoms: icterus, asterixis, ascites, known esophageal varices, total bilirubin \>20 micromol/L, FV \<70%),
* Cirrhosis (known histological liver fibrosis)
* Renal failure with clearance \<30 ml/min O Autoimmune disease O Hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome
* Patients taking fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, oestrogenotherapy, quinolones, carbamazepine, rifampicin
* Other concomitant trauma than lower limb fracture(s)
* Surgery scheduled in more than 5 days
* Patient under mechanical ventilation
* Patient refusing to participate
* Patient not talking / understanding French (delirium assessment impossible)
* Patient already participating to another interventional study
* No signed informed consent,
* No affiliation to a social security regime
Secondary Exclusion Criteria:
Secondary exclusion (before randomization): diagnosis of delirium at the CAM assessment at inclusion, or creatinin clearance \<30 ml / min and /or biological signs of hepatocellular insufficiency (bilirubin\> 20 umol/l and factor V \<70%) if samples not available during the anesthesiologist consultation and so performed after inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT04335968
Study Brief:
Protocol Section:
NCT04335968