FINISHER – Fight INflammation to Improve outcome after aneurysmal Subarachnoid HEmorRhage

Phase 1

Recruiting

Conditions: Aneurysmal Subarachnoid Hemorrhage (SAH)
MedDRA version: 21.1Level: PTClassification code: 10042316Term: Subarachnoid haemorrhage Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-512314-17-00

Lead Sponsor: Rheinische Friedrich-Wilhelms-Universitaet Bonn

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 334

Inclusion Criteria

Male or female subjects, equal or older than 18 years old, Written consent to participate in the study by the patient or his legal representative (emergency inclusion by next of kin or consultant physician under the responsibility of the principal investigator is possible)), Confirmed diagnosis of aneurysmal SAH and onset within 48 hours before inclusion

Exclusion Criteria

SAH due to any other cause than aneurysm rupture (e.g. traumatic, arteriovenous malformation (AVM), fistula, dissection), Known ulceration in the gastro-intestinal tract, History of gastro-intestinal bleeding, Long-term treatment with corticosteroids prior SAH, Any condition that, in the judgement of the Investigator, could impose hazards to the patient if study therapy is initiated or affects the participation of the patient in the study, Patients with obvious evidence of irreparable brainstem or thalamic injury, Patients with foreseeable difficulties to attend follow-ups adequately, Subjects with a physical or psychiatric condition which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s participation in this clinical trial, Current positive pregnancy test (e.g. ß-HCG test in serum), Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure, Severe infectious diseases (in discretion of the local investigator by clinical and laboratory parameters e.g. CRP, PCT, WBC, IL-6), Known angle-closure or open angle glaucoma

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To analyze impact on outcome of an anti-inflammatory treatment with dexamethasone in patients with acute aneurysmal subarachnoid hemorrhage with or without an initial inflammatory signature in peripheral blood compared to placebo.;Secondary Objective: Analysis of improvement in survival rate, Analysis of improvement in recovery time in patients receiving dexamethasonen after aSAH, Analysis of delayed ischemic neurological deficit (DIND), Analysis of symptomatic vasospasm, Analysis of inflammation parameters, Evaluation of quality of life (QoL), Safety analysis of dexamethasone for treatment in patients suffering from SAH;Primary end point(s): Comparison of combined mortality and severe disability between study arms, assessed by the modified Rankin Scale (mRS) 6 months after the subarachnoid hemorrhage - dichotomized in favourable (mRS 0-3) versus unfavourable (mRS 4-6) outcome.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):a) Analysis of mortality at 7, 90 and 365 days after aSAH b) Comparison of time of death in patients;Secondary end point(s):Length of ICU stay and hospitalization after aSAH;Secondary end point(s):Delayed ischemic neurological deficit (DIND);Secondary end point(s):Symptomatic vasospasm measured by transcranial doppler / computed tomography scans / MR angiography / angiography;Secondary end point(s):Level of inflammation parameters such as CRP, PCT, WBC, IL-6 in serum;Secondary end point(s):Analysis of SF36 scores and EQ-ED scores in patients on discharge and at 90, 180 and 365 days after aSAH;Secondary end point(s):Analysis of AEs by number, severity, relationship