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临床试验/NCT02242084
NCT02242084终止2 期

Thrombolysis in Ischemic Spinal Cord Stroke

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
12
试验地点
1
主要终点
Modified Ranking Scale (mRS)

研究概览

简要总结

Ischemic stroke of the spinal cord is a rare disease accounting for about 1% of all ischemic events in the central nervous system (CNS). In most cases the consequences are catastrophic, with a high rate of severe functional disability and mortality rate up to 30%.

Ischemic stroke of the spinal cord can arise from:

  1. Dissection of the aorta.
  2. Aneurism in the aorta.
  3. Atherosclerotic disease of the aorta or vertebral arteries.
  4. Spinal surgeries.
  5. Spinal AVM.
  6. Embolism from cardiac origin.
  7. Occlusion of radicular artery. Onset is usually sudden, reaching maximal intensity in hours until the patient becomes paralyzed in two or in all four limbs. In most cases the damage is in the Anterior Spinal Artery (ASA). The disease is expressed with motor weakness accompanied by disturbance of temperature and superficial sensation, urinary retention or bowel disorder, with preserved position and vibration sense.

The differential diagnosis of ischemic spinal cord includes diseases such as acute myelitis of the spinal cord or acute demyelinating polyneuropathy like Guillan Barree Syndrome (GBS). Therefore in order to reach the appropriate diagnosis in most cases an urgent MRI of the spinal cord is necessary upon arrival in the emergency department.

One of the treatments to acute ischemic stroke is providing thrombolysis. As tested and validated in numerous studies for ischemic events in the brain, until today no validated study in ischemic spinal stroke using thrombolysis has been completed.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with vascular risk factors
  • Patients with sudden weakness of the lower or upper limbs together with bowel disorder.
  • Window treatment - not over 6 hours since the start of the event till the start of the treatment.
  • Patient without dissection of the aorta in the abdomen.
  • Patient without contraindication to IVtPA.
  • Patient with no etiology found after clarification.

排除标准

  • Refusal to sign an ICF.
  • Reason for weakness is known.
  • Patient with contraindication IVtPA.

研究组 & 干预措施

Alteplase treatment

Experimental

All subject who enter the trial will receive treatment with Alteplase along with questionnaire.

干预措施: Intravenuse Alteplase (Drug)

结局指标

主要结局

Modified Ranking Scale (mRS)

时间窗: 3 month post thrombolysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

israel Steiner

Head of Neurology Department

Rabin Medical Center

研究点 (1)

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