An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,839
- 试验地点
- 13
- 主要终点
- Measure: A composite of death or dependency, with dependency being defined by a score of 3 to 5 on the modified Rankin Scale (mRS)
研究概览
简要总结
600 patients wiil be recruited in India into the study. The recruitment has began in August 2010..Patients will be randomised to either intensive blood pressure lowering or current guideline based management. As the trial is an assessment of blood pressure (BP) management policies, there is some flexibility in the use of particular BP lowering agents to achieve BP targets. Intravenous treatment protocols, based on available medications, are provided. Only licensed drugs are used such as labetolol hydrochloride, metoprolol tartrate, hydralazine hydrochloride, glyceral trinitrate and phentolamine. Intensive therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140 mmHg within 1 hour and to maintain this pressure over the next 7 days of the patient's period of hospitalisation. Where possible, oral (or nasogastric) treatment should also be commenced within 24 hours. Control group therapy will include less intensive management of BP using similar choice of route and agents if systolic blood pressure rises above 180 mmHg. The blood pressure target for the control group according to guidelines is a systolic of 180 mmHg. In-person or telephone based follow-up of surviving patients is planned for 3 months in both groups.22 patients have been randomized till date in the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient older than 18 years old (there is no upper age limit).
- •2.Acute stroke syndrome due to spontaneous ICH, confirmed by clinical history and CT scan 3.At least two systolic BP measurements of more than or equal to 150 mmHg and less than or equal to 220 mmHg, recorded 2 or more minutes apart.
- •4.Able to commence randomly assigned BP lowering regimen within 6 hours of stroke onset.
- •5.Able to be ‘actively’ treated and admitted to a monitored facility.
排除标准
- •Exclusion criteria:1.Clear indication or contraindication to intensive BP lowering.
- •2.Evidence ICH secondary to a structural abnormality 3.Recent (within 1 month) use of a thrombolytic agent 4.Previous ischaemic stroke within 30 days 5.A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria 6.Score of 3-5 on the Glasgow Coma Scale (indicating deep coma) 7.Significant pre-stroke disability or advanced dementia 8.Planned early neurological intervention 9.Participation in another clinical trial.
- •10.A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
结局指标
主要结局
Measure: A composite of death or dependency, with dependency being defined by a score of 3 to 5 on the modified Rankin Scale (mRS)
时间窗: Time Frame: 90 days
次要结局
- To assess the effect of the treatment on the primary outcome in a subgroup of patients who receive treatment within 4 hours of ICH onset.(Other secondary outcomes)