Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 334
- 试验地点
- 13
- 主要终点
- modified Rankin Scale (mRS) at 6 months after SAH
研究概览
简要总结
Aneurysmal subarachnoid hemorrhage (SAH) is a fatal disease with high morbidity and mortality. While the primary injury results from the initial bleeding and cannot be influenced, secondary injury through vasospasms and delayed cerebral ischemia (DCI) during the course of the disease might be a target for intervention in order to improve outcome. To date, beside the aneurysm treatment to prevent re-bleeding and the administration of oral nimodipine, there is no causal therapy available, so that novel treatment concepts are desperately needed. There are strong indications that inflammation contributes to DCI and therefore poor outcome and plays a major role in SAH. Some studies suggest a beneficial effect of anti-inflammatory drugs like glucocorticoids (GC) in SAH patient, but there are no data from randomized controlled trials proving or disproving the beneficial effect of GC, so that current guidelines do not recommend the use of GC in SAH so far.
This multi-center trial aims to generate the first confirmatory data in a controlled randomized fashion that dexamethasone (DEX) improves the outcome in a clinically relevant endpoint in SAH patients. Moreover, this trial will generate first data in a secondary analysis, whether the initial inflammatory state of SAH patients defines a subgroup that particularly responds to a treatment with DEX.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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)
- •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
- •Known angle-closure or open angle glaucoma
- •Known ulceration in the gastro-intestinal tract
- •History of gastro-intestinal bleeding
- •Long-term treatment with corticosteroids prior SAH
研究组 & 干预措施
Experimental arm
3 x 8 mg (2 ml) dexamethasone daily for days 1-7 and 1 x 8 mg (2 ml) dexamethasone daily for days 8-21 in addition to aneurysm treatment and best medical intensive care of SAH patients
干预措施: Dexamethasone (Drug)
Control arm
3 x 2 ml Placebo daily for days 1-7 and 1 x 2 ml Placebo daily for days 8-21 in addition to aneurysm treatment and best medical intensive care of SAH patients
干预措施: Placebo (Drug)
结局指标
主要结局
modified Rankin Scale (mRS) at 6 months after SAH
时间窗: 6 months
Dichotomized modified Rankin Scale (mRS) 6 months after subarachnoid haemorrhage. The dichotomization will be done in the classes "favourable" (mRS 0-3) versus "unfavourable " (mRS 4-6) outcome.
次要结局
未报告次要终点
研究者
Erdem Güresir, MD
Prof. Dr. Erdem Güresir
University of Leipzig