patient with cerebral hemorrhage MedDRA version: 9.1 Level: SOC Classification code 10047065
Conditions
Interventions
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
Concentration type: equal
Sponsors
ISTITUTO NEUROLOGICO MEDITERRANEO NEUROMED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. patients with subarachnoid hemorrage eligible for both neurosurgical and endovascular treatment 2. patients in treatment with nimodipine and or triple H therapy 3. Age 18/70 4. Subjects willing and able to give written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. subjects with clinically significant medical or surgical condition that could preclude a safe and complete participation to the study 2. pregnancy 3. concomitant treatment disallowed by the product SPC 4. subjects who assumed experimental treatment in the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effectiveness and safety in the use of Infliximab in preventing or reducing cerebral vasospam evoked by subarachnoid hemorrhage;Secondary Objective: ;Primary end point(s): effectiveness in the use of Infliximab in preventing cerebral vasospam by measuring percentage both the grade of vasospam and percentage of patients without vasospam (both early and late) between the two groups. effectiveness in the use of Infliximab of this therapy in reducing vasospam once symptomatic by measuring the percentage of the phenomenon reduction and clinical amelioration by use of evaluation scale (Rankin, GOS) diagnostical instruments ( Transcranial doppler, Angio Tac and Angio RM) and clinical practice | — |
Countries
Italy
Outcome results
None listed