2024-515994-83-00招募中3 期
MIVAR - Milrinone Infusion for VAsospam treatment in subarachnoid hemoRrhage
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 370
- 试验地点
- 15
- 主要终点
- The main primary end point is proportion of patients with a good outcome at 3 months(defined as a modified Rankin (mRS) score ≤2)
研究概览
简要总结
The main objective is to evaluate the efficacy of Milrinone intravenous infusion compare to placebo to improve the neurological outcome at 3 months in patients with vasospasm following an aneurysmal SAH.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult patients hospitalized for aneurysmal subarachnoid hemorrhage
- •Diagnosis of vasospasm confirmed on cerebral angiographic CT-scanner
- •Delay between diagnosis of vasospasm (i.e. CT-scanner) and inclusion ≤ 6 hours
- •Patients consent or patient’s relative (or emergency procedure)
排除标准
- •Initial Glasgow score = 3 with bilaterally mydriasis
- •Non-affiliation to French health care coverage
- •Pregnant, nursing or parturient woman
- •Adult patient deprived of liberty by legal or administrative decision
- •Adult patient with psychiatric care under duress
- •Adult patient protected under the law (guardianship)
- •Inclusion in an other interventional study modifying usual vasospasm management
- •Moribund patient
- •Contraindication to Milrinone (notably obstructive cardiomyopathy)
- •Cerebral infarction in the vasospasm area already present on the CT-scanner at the time of diagnosis (lack of expected benefit of treatment according to medical judgement)
- •Cardiac failure needing ionotropic administration when randomization has to be performed
- •Not controlled Intracranial Hypertension when randomization has to be performed
- •(ICP > 25 mmHg during at least 20 min)
- •Flutter patient or with cardiac aryhtmiaby atrial fibrillation poorly tolerated
- •Major hydroelectric problems (hypokaliémia <3 mmol/L)
结局指标
主要结局
The main primary end point is proportion of patients with a good outcome at 3 months(defined as a modified Rankin (mRS) score ≤2)
The main primary end point is proportion of patients with a good outcome at 3 months(defined as a modified Rankin (mRS) score ≤2)
次要结局
- mortality in intensive care unit, in hospital, at 3 months and 6 months after aneurysm rupture
- long term clinical outcomes with modified Rankin score at 6 months and Glasgow Outcome scale Extended (GOS-E) score at 3 and 6 months
- the long term quality of life with EQ-5D at baseline, 3 and 6 months
- effectiveness of the treatment on radiologic term Angiographic success at D7 and D14 according to angiographic CTscanner with blind radiologist’s analysis (coted as follows: No success, light success, moderate success or important success), The volume of infarcted areas measured using the control MRI, done between 1 and 3 months after aneurysm rupture.
- To describe flow velocity variations in middle cerebral artery due to treatment
- length of hospitalization in intensive care unit and in hospital (including recovery centers)
- To evaluate the length of hospitalization in intensive care unit and in hospital (including recovery centers)
- hemodynamic tolerance :need to introduce and/or increase doses of catecholamines by + 50% during the first 24 hours (% of patients and mean doses of treatment)
- metabolic tolerance : The occurrence of dysnatremia (<135 mmol / L or> 155 mmol / L), Daily diuresis.
研究者
Sigismond Lasocki
Scientific
Centre Hospitalier Universitaire D'Angers
研究点 (15)
Loading locations...
相似试验
进行中（未招募）
不适用
Administration of the approved drug milrinone via venous access to treat and to prevent vasospasmSAB-induced vasospasmEUCTR2009-016620-32-ATDept. of Neurological Surgery, Medical University of Vienna
已完成
3 期
Milrinone Infusion for VAsospam Treatment in Subarachnoid hemoRrhageVasospasmNCT04362527University Hospital, Angers370
尚未招募
2 期
Milrinone infusion for cerebral vasospasm in aneurysmal sub-arachnoid haemorrhage patients: a pilot randomised controlled studyACTRN12622001405707Monash Medical Centre40
招募中
2 期
Effect of Milrinonein treatment vasospasm in patients with ?subarachnoid hemorrhagesubarachnoid hemorrhage.Nontraumatic subarachnoid hemorrhageIRCT20141209020258N82Arak University of Medical Sciences32
尚未招募
3 期
Intravenous infusion of a single solution with with midazolam and fentanyl versus intravenous infusion of midazolam and fentanyl in separate solutionsRespiratory failureSepseC08.618.846C01.539.757RBR-3j6rdgHospital do Servidor Público Municipal