Aneurysmal Subarachnoid Hemorrhage (aSAH) MedDRA version: 20.1 Level: LLT Classification code 10042320 Term: Subarachnoid hemorrhage System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: NIMODIPINE
CAS Number: 66085-59-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10 m
Sponsors
Medical Center -University of Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged =18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Surgical contraindications according to the opinion of the investigator 3. Inability to administer study medication (known allergy to urokinase or nimodipine) 4. Presence of a severe illness prior to aSAH (e.g. progressive cancer, terminal organ failure, severe neurological disorder, life expectancy < 1 year) 5. Known and persistent abuse of medication or drugs 6. Presence of severe cerebral infarction related to the aSAH or medical procedures prior to randomization 7. Presence of intracerebral hematoma that is = 30ml (assessed using the AxBxC/2 method)5 or in eloquent location prior to randomization 8. Presence of a condition or abnormality that in the opinion of the Investigator would compromise safety of the patient 9. Known severe complications during aneurysm securing (e.g. dissections of blood vessels, vessel occlusions, re-hemorrhage) 10. Clinical signs of brain stem / midbrain compression (dilated pupil not reacting to light) persisting for more than 45 minutes at any time between aSAH onset and randomization 11. Persons who are in a relationship of dependence/employment with the sponsor or the investigator 12. For MRI follow-up: cardiac pacemaker and/or cardiac defibrillator. Stent implantation within the last 6 weeks prior to MRI, claustrophobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether cisternal lavage therapy with Urokinase, Ringer's solution and Nimodipine administered via a stereotactically implanted catheter into the prepontine cistern (IT, Investigational Treatment) improves neurological outcome and is safe in patients with aSAH.;Secondary Objective: To assess whether cisternal lavage therapy with Urokinase and Nimodipine administered via a stereotactically implanted catheter into the prepontine cistern (IT, Investigational Treatment) improves neurological outcome and is safe in patients with aSAH.;Primary end point(s): Neurological outcome: Proportion of subjects with a favorable outcome measured on the modified Rankin Scale (mRS) at 6months after aSAH, assessed by an independent physician. mRS will be analyzed in a dichotomized fashion: favorable, defined as: mRS 0-3 (independent) vs. unfavorable, defined as: mRS 4-6 (dependent/dead);Timepoint(s) of evaluation of this end point: 6 months after aSAH | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - mRS at 12 months after aSAH - Neuropsychological outcome -- Cognitive performance (Montreal Cognitive Assessment) at 6 months following aSAH -- Health-related quality of life (SF-36) at 6 months -- Fatigue, anxiety and depressive symptoms (Frontal Systems Behavior Scale, Multidimensional Assessment of Fatigue, Hospital Anxiety and Depression Scale), Post-traumatic stress disorder (Impact of Event Scale – R) at 6 months -- Return-to-work parameters at 6 and 12 months - Rate and severity of delayed cerebral infarction (DCI) according to the Vergouwen criteria - Rate of delayed ischemic neurological deficit (DIND), defined as clinical deterioration caused by delayed cerebral ischemia (i.e. a new focal neurological deficit or decline on the Glasgow Coma Scale of 1 point not attributable to other causes) on days 3 – 21. (Note: The date of aSAH occurrence is defined as day 0.) - Delta mean flow velocities of both middle cerebral arteries – measured by transcranial Doppler-ultrasonography on days 3 – 15. - NIHSS score at day 32 and at 6 months - Rates of shunt-dependent hydrocephalus at 6 months following aSAH - Rate of endovascular interventions for the treatment of cerebral vasospasm - Key parameters of endocrinological dysfunction - Morphological brain damage at 6 months after aSAH as assessed by MRI - Key markers of neuronal injury and systemic inflammation in patient blood - electroencephalographic patterns as measured by continuous EEG-monitoring during intensive care period (exploratory endpoint) - Safety of IT: (Serious) Adverse Events related to the IT;Timepoint(s) of evaluation of this end point: Timepoints of evaluations are included in the description of the respective endpoints | — |
Countries
Germany
Contacts
Public ContactCoordinating Investigator
Universitätsklinikum Freiburg
Outcome results
None listed