NCT01298830终止1 期
GLP-1 CellBeads® for the Treatment of Stroke Patients With Space-occupying Intracerebral Hemorrhage
CellMed AG, a subsidiary of BTG plc.6 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 6
- 主要终点
- The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage
研究概览
简要总结
The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Confirmed diagnosis of intracerebral hemorrhage or subarachnoid hemorrhage in conjunction with ICH by cranial computed tomography (CCT) or Magnetic Resonance Tomography (MRT)
- •Patients who need by judgement of a clinical neurologist or neurosurgeon surgical removal of the blood clot due to its space-occupying effects
- •Age greater or equal 18 years for men
- •Age greater or equal 18 years for women if confirmed infertility (e.g. hysterectomy or surgical sterilisation at least 3 months before study start)
- •For all other women age greater or equal 50 years with last menstrual bleeding at least one year before study start
- •Minimum hematoma diameter of 2 cm as measured in baseline CCT or MRT
- •Signed, written informed consent of patient or consent/assertion from the patient's legally acceptable representative/affiliated if the patient is unable to provide informed consent
排除标准
- •Participation in any other clinical trial within the past 3 months or ongoing
- •Occurrence of inconsistency with initial diagnosis at baseline during surgery of the patient leading to unfulfilled inclusion criterion Hemorrhage secondary to tumour or trauma
- •Patients with a cerebellar hemorrhage or extension of a supratentorial hemorrhage into the brainstem
- •Patients with severe pre-existing physical or mental disability or severe comorbidity that interferes with the assessment of outcome
- •Allergy to contrast media (MRT)
- •Acute infection
- •Muscular, neurological, or vascular insufficiency of the respective tissue
- •Polypropylene incompatibility
- •Acute immunosuppressive medication
- •Patient after organ transplantation
- •Patient with immune depression
- •Patients with a high probability of spontaneous recovery or showing rapidly improving signs
- •Patients with extensive intracranial hemorrhages or with deep hemispheric localisation of the clots
- •Patients whose diagnosis of ICH is uncertain
研究组 & 干预措施
GLP-1 CellBeads
Experimental
干预措施: GLP-1 CellBeads (Drug)
结局指标
主要结局
The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage
时间窗: 6 months
次要结局
- Neurological conditions(6 months)
研究者
研究点 (6)
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