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临床试验/NCT01206283
NCT01206283已完成不适用

Modified Lund Concept Versus Cerebral Perfusion Pressure-targeted Therapy: A Randomized Controlled Study in Patients With Secondary Brain Ischaemia.

University of Sarajevo2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Mortality rate

研究概览

简要总结

Secondary brain ischaemia (SBI) usually develops after aneurysmal subarachnoid haemorrhage (SAH) and severe traumatic brain injury (TBI). The current management strategies are based on intracranial pressure-targeted therapy (ICP-targeted) with cerebral microdialysis monitoring (modified Lund concept) or cerebral perfusion pressure-targeted therapy (CPP-targeted). We present a randomised controlled study to compare the two management strategies.

The hypotheses of the study were:

  • SBI developed after aneurysmal SAH and severe TBI share the same crucial characteristics and any treatment applied will essentially treat the same underlying pathophysiology.
  • ICP-targeted therapy with cerebral microdialysis monitoring according to the modified Lund concept is superior to CPP-targeted therapy in managing comatose patients with SBI after aneurysmal SAH and severe TBI.

Sixty comatose operated patients with SBI following aneurysmal SAH and severe TBI were randomized into ICP-targeted therapy with cerebral microdialysis monitoring and CPP-targeted therapy groups. Mortality rates in both groups were calculated and biochemical signs of cerebral ischaemia were analysed using cerebral microdialysis. Outcome for cerebral microdialysis was measured as poor outcome (Glasgow Outcome Scale score 1, 2 and 3) or good outcome (Glasgow Outcome Scale score 4 and 5).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with subarachnoid haemorrhage who had anterior circulation aneurysm rupture only
  • multiple anterior aneurysm rupture
  • severe traumatic brain injury with isolated head injury and intradural focal lesions only

排除标准

  • Glasgow Outcome Score of 3 with or without brainstem reflexes
  • Significant co-morbidities
  • posterior circulation aneurysm
  • multisystem injuries
  • diffuse axonal injuries

结局指标

主要结局

Mortality rate

时间窗: 18 months

Measurement of outcome was done using the Glasgow Outcome Scale (GOS) after each specific intervention in all the patients. GOS 1 - dead, 2- vegetative, 3- severe disabled, 4- moderate disabled, 5- independent.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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