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临床试验/NCT01773200
NCT01773200Unknown不适用

Prognostic Value of Circulating Endothelial Progenitor Cells in Aneurysmal Subarachnoid Hemorrhage (Evaluation de l'intérêt Pronostic Des progéniteurs endothéliaux Circulants Dans l'hémorragie Sous-arachnoïdienne Par Rupture d'anévrysme cérébral)

Centre Hospitalier Universitaire de Besancon1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
92
试验地点
1
主要终点
endothelial progenitor cells count

研究概览

简要总结

Aneurysmal subarachnoid hemorrhage is a common and serious disease associated to a high rate of mortality and morbidity. Severe definitive neurological impairment can concern up to 30% of patients in relation with elevated intracranial pressure, hemorrhage recurrence and symptomatic cerebral arterial vasospasm. This latter complication is defined as a reversible reduction of cerebral artery's diameter occurring between the 4th and the 14th day after bleeding. Physiopathology is not well understood, but could involve endothelium, trough endothelial progenitor cells (EPC). Circulating EPC are bone marrow-derived cells with capacity of vasculogenesis and angiogenesis. EPC have been recognized playing a beneficial role in cardiovascular disease and ischemic stroke. EPC have never been studied in aneurysmal subarachnoid hemorrhage.

The primary objective of this study is to compare the number of circulating endothelial progenitor cells between patients with a good neurological outcome (defined as a glasgow outcome scale = 1 or 2) and patients with a poor neurological outcome (glasgow outcome scale = 3, 4 or 5).

Briefly, the number of circulating EPC will be measured at admission, and at day 3, 6, 10, 14, 21 in each consecutive patient suffering aneurysmal subarachnoid hemorrhage and hospitalized in Teaching Hospital of Besançon (France). The neurological outcome will be measured one year after subarachnoid hemorrhage.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • recent(< 24 h) aneurysmal subarachnoid hemorrhage
  • written informed consent obtained from the patient or from close relatives

排除标准

  • refusal to participate
  • Non-aneurysmal subarachnoid hemorrhage
  • aneurysmal subarachnoid hemorrhage with estimated date of bleeding > 24 h
  • Chronic heart failure
  • Chronic medication able to modify the plasmatic level of BNP
  • Pregnancy

结局指标

主要结局

endothelial progenitor cells count

时间窗: day 3 after bleeding

次要结局

  • Plasmatic brain natriuretic peptide(day 0, 3, 6, 10, 14, 21 after bleeding)
  • Endothelial progenitor cells count(day 0, 6, 10, 14, 21 after bleeding)
  • Maximal amplitude of variation of EPC count(3 weeks after bleeding)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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