This prospective, multicenter, open-label clinical trial is designed to evaluate the safety and efficacy of rapamycin in the treatment of communicating hydrocephalus secondary to intraventricular hemorrhage. Additionally, the underlying pathogenic mechanisms associated with this particular type of hydrocephalus will be investigated in greater depth, and populations that may benefit from rapamycin therapy will be identified.
Patients with ventricular dilatation due to intraventricular hemorrhage who clinically present with any one or more of new gait disturbances, cognitive deficits, and urinary incontinence after remission of intraventricular hemorrhage symptoms, and whose brain imaging shows an Evans index (EI) of ≥0.3
Age ≥ 18 years and ≤ 70 years
Signed informed consent form
Participation in another medical trial
Have other disease that may affect the patient's symptoms (including gait disturbance, cognitive impairment, urinary incontinence)
Allergy to the investigational drug
Reduced liver function (increased INR or alanine transaminase concentrations in plasma elevated more than 1.5 times reference values)
Single group
Rapamycin
DrugAll enrolled patients receive treatment with sirolimus (rapamycin)#The prescribed regimen involved a daily oral dosage of 1.5 mg for a duration of four weeks.
The objective remission rate of rapamycin for 4 weeks in the treatment of communicating hydrocephalus secondary to intraventricular hemorrhage is evaluated using the Idiopathic Normal Pressure Hydrocephalus Grading Scale (IPNHGS).
Disease relief: Improvement of \>1 point on the Idiopathic Normal Pressure Hydrocephalus Grading Scale (iPNHGS) in patients after four weeks of rapamycin treatment compared to pre-treatment. Objective remission rate: The ratio of the number of patients who have achieved disease remission to the total number of patients enrolled in the study.
Assessment of the incidence and severity of adverse events, serious adverse events, and other safety parameters (e.g., abnormal laboratory results) based on CTCAE V5.0
All events are determined based on CTCAE V5.0
The objective remission rate of rapamycin treatment of communicating hydrocephalus secondary to intraventricular hemorrhage is evaluated using the Idiopathic Normal Pressure Hydrocephalus Grading Scale (IPNHGS).
Disease relief: Improvement of \>1 point on the Idiopathic Normal Pressure Hydrocephalus Grading Scale (iPNHGS) in patients after four weeks of rapamycin treatment compared to pre-treatment. Objective remission rate: The ratio of the number of patients who have achieved disease remission to the total number of patients enrolled in the study.
The objective remission rates of 3 clinical domains is evaluated using the Idiopathic Normal Pressure Hydrocephalus Grading Scale (IPNHGS).
The 3 clinical domains include: gait, urinary incontinence, and cognition. For gait, positive outcome was defined that improvement of \>1 point in the gait section of iNPHGS; for urinary incontinence, a positive outcome was defined that improvement of \>1 point in the urinary section of iNPHGS; For cognition, positive outcome was defined that improvement of \>1 point in the cognition section of iNPHGS
Changes in plasma biomarkers
Change in plasma levels of TNF-α, IL-1β, IL-6, IL-10, IL-8 and IL-2R.
Screening of potential beneficiary population
Identification of a patient population with secondary communicating hydrocephalus after intraventricular hemorrhage that may benefit from rapamycin therapy.
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