NL-OMON38214已完成3 期
Induced hypertension for treatment of delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage. - Induced hypertension for DCI after SAH.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •1. Admission to the hospital 2. Age 18 years or over 3. Aneurysmal SAH, demonstrated on CT-angiography or cerebral angiograph 4. DCI (decrease of at least one point on the GSC sumscore, unless the decrease doesn*t reflect DCI as evaluated by the treating physician, and/or all new neurological focal deficits), diagnosed by a neurologist, neurosurgeon or intensivist, 5. Informed consent
排除标准
- •0. Evidence of DCI after the SAH at time of asking for informed consent, unless symptoms of DCI started within 3 hours 1. Co-existing severe head injury. 2. A perimesencephalic haemorrhage. 3. A history of a ventricular cardiac rhythm disorder, necessitating medical treatment. 4. A history of left ventricular heart failure, necessitating medical treatment. 5. Pregnancy. 6. Transferral to another hospital, 7. moribund, 8. Other cause for neurological deterioration (see page 19 of the study protocol for the differential diagnosis) 9. Symptomatic cerebral aneurysm not yet treated by coiling or clipping, 10. Severe hypertension, defined as a spontaneous MAP of 120 mmHg or more at the moment of evaluation for trial participation, 11. Any contraindication for induced hypertension (such as a cardiac complication necessitating medical treatment) as evaluated by the treating physician. And furthermore, in selected centres where the sub study with CT perfusion will be performed: 12. known allergy for CT-contrast agents. 13. renal failure, defined as a serum creatinine > 150 µmol/l, because of the risk of contrast nephropathy. 14. diabetes mellitus.
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