2024-512314-17-00招募中3 期
FINISHER – Fight INflammation to Improve outcome after aneurysmal Subarachnoid HEmorRhage
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 334
- 试验地点
- 14
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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. β-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
结局指标
主要结局
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.
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.
次要结局
- a) Analysis of mortality at 7, 90 and 365 days after aSAH b) Comparison of time of death in patients
- Length of ICU stay and hospitalization after aSAH
- Delayed ischemic neurological deficit (DIND)
- Symptomatic vasospasm measured by transcranial doppler / computed tomography scans / MR angiography / angiography
- Level of inflammation parameters such as CRP, PCT, WBC, IL-6 in serum
- Analysis of SF36 scores and EQ-ED scores in patients on discharge and at 90, 180 and 365 days after aSAH
- Analysis of AEs by number, severity, relationship
研究者
Prof. Dr. Erdem Güresir
Scientific
Rheinische Friedrich-Wilhelms-Universitaet Bonn
研究点 (14)
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