A multicenter, open label, hystorical Group controlled study by evaluate the effectivness and sAfety in theuse of INfliximab (Tumor necrosis factor - alfa antibody) in preventing or reducing cerebral vasospamevoked by subarachnoid hemorrhage - GAI

• Conditions: patient with cerebral hemorrhage; MedDRA version: 9.1Level: SOCClassification code 10047065

• Registration Number: EUCTR2009-017448-15-IT
• Lead Sponsor: ISTITUTO NEUROLOGICO MEDITERRANEO NEUROMED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the effectiveness and safety in the use of Infliximab in preventing or reducing cerebral vasospam evoked<br>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<br>vasospam and percentage of patients without vasospam (both early and late) between the two groups.<br>effectiveness in the use of Infliximab of this therapy in reducing vasospam once symptomatic by measuring the<br>percentage of the phenomenon reduction and clinical amelioration by use of evaluation scale (Rankin, GOS)<br>diagnostical instruments ( Transcranial doppler, Angio Tac and Angio RM) and clinical practice