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临床试验/NCT06303349
NCT06303349已完成不适用

Predictive Model for the Occurrence of Cerebral Vasospasm Complicating Subarachnoid Haemorrhage by Combined Analysis of the Kinetics of a Panel of Biomarkers.

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2024年5月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
155
试验地点
1
主要终点
Occurrence of cerebral vasospasm

研究概览

简要总结

The objective is to create a dynamic clinical prediction model that includes routinely measured care and biological biomarkers to predict cerebral vasospasm within 14 days of bleeding in patients treated in the neurosurgical intensive care unit for subarachnoid hemorrhage.

Patients admitted to intensive care will be followed for up to 14 days (D14 time horizon of interest), or until discharge from intensive care if earlier.

Blood samples will be taken from D1 to D10 to isolate the blood biomarkers of interest for each patient.

The measurement of biomarkers and cerebral vasospasm will be blinded to each other.

详细描述

Subarachnoid hemorrhage (SAH) is the rupture of a cerebral aneurysm, resulting in bleeding into the subarachnoid space.

This condition has significant morbidity and mortality. The patient's functional outcome is primarily determined by the severity of cerebral ischemic lesions that develop during the first few weeks after the acute phase. The main focus of resuscitation management in patients are the 'delayed ischemic lesions'. These lesions are caused by various phenomena, with vasospasm being the most common mechanism. The caliber of cerebral arteries will shrink, reducing the blood flow delivered to the parenchyma, leading to a deficit of energy metabolites in neurons and causing their death. This complication typically occurs within a well-defined time frame, ranging from 3 to 21 days after bleeding, and peaking around the seventh day.

The objective of this study is to create a novel predictive method for symptomatic vasospasm. This method will incorporate routine clinical and radiological biomarkers, as well as innovative biological assays. The aim is to enable earlier diagnosis and even pre-emptive treatment of this pathology.

Several studies have examined the predictive potential of various blood biomarkers for neurological prognosis and the incidence of delayed brain damage in patients. These studies have demonstrated strong associations between them. For instance, one study found that patients with the most severe vasospasm had a significantly higher peak in cerebrospinal fluid of several biomarkers associated with neurodegeneration, such as Neuron Specific Enolase (NSE). Additionally, the plasma concentration-time curves demonstrated simultaneous elevations during periods of vasospasm.

However, no study has examined the practical clinical use of these biomarkers during hospitalization to predict the occurrence of vasospasm on a daily basis or at specific times of interest. This is particularly important as the pathophysiological time sequence appears to be common to all patients. A single study has attempted to establish a predictive algorithm for delayed cerebral lesions, achieving a certain degree of effectiveness (over 90% correct predictions and sensitivity of around 93%), by combining a single biomarker assay and clinical parameters. However, this study only focuses on ischemic lesions at 6 weeks and cannot be used to guide therapy during initial management.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • •Subarachnoid hemorrhage (of aneurysmal or non-aneurysmal etiology) less than 4 days prior to admission to neuro-resuscitation, diagnosed on clinical presentation and confirmed by brain imaging.
  • •Free, informed and written consent signed by the patient (or, failing this, his or her representative).
  • •Patient entitled to or affiliated with social security

排除标准

  • •Significant vasospasm on admission to the department, diagnosed on initial imaging
  • •Patient whose short-term survival (48 hours) appears compromised
  • •Contraindication to perfusion CT scan
  • •Pregnant or breast-feeding women
  • •Patient under legal protection (persons deprived of liberty or under guardianship)

研究组 & 干预措施

experimental arm

Experimental

Patients with subarachnoid hemorrhage, whether aneurysmal or non-aneurysmal, who were admitted to the neuro-resuscitation unit within four days of onset.

Diagnosis was based on clinical presentation and confirmed by brain imaging

干预措施: Samples collection (Other)

结局指标

主要结局

Occurrence of cerebral vasospasm

时间窗: Day 14 after inclusion

Occurrence of cerebral vasospasm within 14 days of ICU (Intensive Care Unit) admission.

次要结局

  • WFNS (World Federation of Neurologic Surgeons) score(up to Day 10 after inclusion)
  • Glasgow score(up to Day 10 after inclusion)
  • Medical Research Council (MRC) score(up to Day 10 after inclusion)
  • PtiO2 (oxygen pressure in the cerebral tissue)(up to Day 10 after inclusion)
  • Transcranial Doppler(up to Day 10 after inclusion)
  • Non-significant angiographic vasospasm(up to Day 10 after inclusion)
  • Non-significant perfusion anomaly(up to Day 10 after inclusion)
  • Cerebral ischemic lesions(up to Day 14 after inclusion)
  • Occurrence of symptomatic vasospasm(up to Day 14 after inclusion)
  • Modified Fisher score(up to Day 10 after inclusion)
  • Non-significant perfusion anomaly(up to Day 10 after inclusion)
  • WFNS (World Federation of Neurologic Surgeons) score(up to Day 10 after inclusion)
  • Glasgow score(up to Day 10 after inclusion)
  • Glasgow Outcome Scale -Extended (GOS-E)(up to Day 14 after inclusion)
  • Biomarkers measurements(Day 10 after inclusion)
  • Medical Research Council (MRC) score(up to Day 10 after inclusion)
  • PtiO2 (oxygen pressure in the cerebral tissue)(up to Day 10 after inclusion)
  • Transcranial Doppler(up to Day 10 after inclusion)
  • Modified Fisher score(up to Day 10 after inclusion)
  • Non-significant angiographic vasospasm(up to Day 10 after inclusion)
  • Cerebral ischemic lesions(up to Day 14 after inclusion)
  • Occurrence of symptomatic vasospasm(up to Day 14 after inclusion)
  • Organ infection(up to 10 days after inclusion)
  • Severe pneumonia(up to 10 days after inclusion)
  • Septic shock(up to 10 days after inclusion)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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