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Characteristics of traumatic intracerebral haemorrhage: An assessment of screening logs from the STITCH(Trauma) Trial

机译:创伤性脑出血的特征:从STITCH(创伤)试验筛查原木的评估

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Introduction. In undertaking international neurosurgical trials it is useful to understand international patient demographics and potential patient populations that study results will apply to. The STITCH(Trauma) trial included 59 centres from 20 countries, which were requested to screen all patients with traumatic intracerebral haemorrhage. This paper reviews these data. Materials and methods. Demographic, clinical and exclusion reason data were analysed. Comparisons were made between patients who were included in the trial and patients who were potentially eligible (but not included in the trial) and patients who were not potentially eligible. Results. Screening evidence was returned for 1735 patients, 11% of these may potentially have been eligible, of whom 52% were not included because consent could not be gained. By country, median age per centre ranged from 26 years (Egypt) to 67 years (Germany), median time from injury to screening ranged from 5 h (Germany and Nepal) to 16 h (India), median intracerebral haemorrhage (ICH) volume ranged from 5ml (Germany) to 30ml (China), the proportion of male patients ranged from 56% (Egypt) to 91% (Canada) and the proportion of patients with both pupils reactive ranged from 68% (China) to 98% (Nepal). The most common exclusion reasons were ICH volume < 10ml (49%) and presence of subdural haemorrhage/extradural haemorrhage or SDH/EDH requiring surgery (20%). Conclusion. Data presented here including international patient demographics and reasons for patient ineligibility will be useful for future traumatic ICH studies.
机译:介绍。在进行国际神经外科手术试验时,了解国际患者的人口统计资料和研究结果将适用于的潜在患者人群很有用。 STITCH(创伤)试验包括来自20个国家的59个中心,这些中心被要求筛查所有创伤性脑出血患者。本文回顾了这些数据。材料和方法。分析了人口统计学,临床和排除原因数据。在纳入试验的患者与可能符合条件(但未纳入试验)的患者和未符合条件的患者之间进行比较。结果。返回了1735名患者的筛查证据,其中11%可能符合条件,其中52%未包括在内,因为无法获得同意。按国家/地区划分,每个中心的平均年龄范围为26岁(埃及)至67岁(德国),受伤至筛查的平均时间范围为5小时(德国和尼泊尔)至16小时(印度),中位数脑出血(ICH)量从5毫升(德国)到30毫升(中国)不等,男性患者的比例从56%(埃及)到91%(加拿大)不等,两个有反应的患者的比例从68%(中国)到98%(尼泊尔)。最常见的排除原因是ICH体积<10ml(49%)和存在硬膜下出血/硬膜外出血或需要手术的SDH / EDH(20%)。结论。此处提供的数据(包括国际患者人口统计信息和患者不合格的原因)将对将来的创伤性ICH研究有用。

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