2024-514242-36-00招募中2 期
LEVOSAH - Pilot study comparing the effectiveness of adding treatment with Levosimendan to usual care for the management of the acute phase of aneurysmal subarachnoid hemorrhages
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- the occurrence of cerebral arterial vasospasm within 14 days of the bleeding
研究概览
简要总结
To assess the efficacy of levosimendan in patients admitted to intensive care for HSAa at high risk of ASV (WFNS Grade I to IV and Fisher score 3 or 4) on the occurrence of ASV.
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
- 是
入选标准
- •All adult patients (≥ 18 to 75),
- •hospitalized in surgical intensive care at Lariboisière for subarachnoid hemorrhage of aneurysm origin
- •(HSAa) clinical score WFNS I to IV and Fisher score 3 or 4.
排除标准
- •Contraindications to levosimendan (including hypersensitivity to levosimendan, severe hypotension, tachycardia, cardiac mechanical obstructions)
- •severe renal impairment (creatinine clearance <30 ml / min)
- •Severe hepatic insufficiency (signs of hepatic encephalopathy);
- •History of torsades de pointes
- •Severe pre-existing neuro-vascular pathologies
- •Moribund patients.
- •pregnant women
结局指标
主要结局
the occurrence of cerebral arterial vasospasm within 14 days of the bleeding
the occurrence of cerebral arterial vasospasm within 14 days of the bleeding
次要结局
- the cumulative incidence of death rate, ICDs and vasospasms
- The mRS score at 6 months
- Impact of Levosimendan treatment on cardiac dysfunction
研究者
Coordinating investigator
Scientific
Assistance Publique Hopitaux De Paris
研究点 (1)
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