Effect of Molar Sodium Lactate Filling on Cerebral Hemodynamics in Patients With Severe Meningeal Hemorrhage Multicenter Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 5
- 主要终点
- median transit time (MTT)
研究概览
简要总结
Subarachnoid hemorrhage by aneurysmal rupture is a serious condition associated with a high mortality rate. Among the complications presented by these patients, vasospasm is one of the main causes of secondary aggravation, in particular the appearance of delayed neurological deficits following the induced cerebral ischemia. Classically occurring between the 4th and 12th day, with a peak on D7, its prevention is currently often ineffective.
In recent years, many studies have shown that sodium lactate could be an interesting product for neuroprotection. In addition to an anti-osmotic effect that has been demonstrated by our team in the context of post-traumatic intracranial hypertension, a metabolic action has also been observed in periods of metabolic attacks induced by brain attacks. Recently, a vasodilatory action of sodium lactate has been observed from an experimental and clinical point of view.
The purpose of this work is to observe the effect of sodium lactate, compared to placebo, on cerebral hemodynamics measured by perfusion CT (Mean Transit Time MTT) in a population of patients with hemorrhage under the arachnoid.
This work is the preliminary work of a study that will investigate the potential preventive protective effect of sodium lactate on the incidence of vasospasm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
paticipant and radiologists are masked
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
- •Any patient over 18 years of age with severe meningeal hemorrhage defined by a WFNS≥3 score will be included in the study.
- •Treated by endovascular embolization or surgically within 48 hours
- •After obtaining the informed consent of the patient, or his relatives if he is not searchable (coma).
- •Affiliation to a social security system
- •After an adapted preliminary medical examination
排除标准
- •Post-traumatic meningeal hemorrhage
- •Management time >48h with respect to bleeding
- •Known neurodegenerative pathology (Alzheimer's, Parkinson's, etc.), Creutzfeldt-Jacob disease
- •Pregnant woman
- •Decision not to treat
- •Refusal to participate in the study
- •Adult patient protected by law
- •Person deprived of administrative or judicial freedom
研究组 & 干预措施
Molar Sodium Lactate
干预措施: Molar Sodium Lactate (Drug)
physiological serum
干预措施: physiological serum (Drug)
结局指标
主要结局
median transit time (MTT)
时间窗: 7 days
median transit time (MTT) in seconds, on the perfusion scanner on 6 regions of the brain between D0 and D7 of the product perfusion
次要结局
未报告次要终点