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
- 不适用
- 状态
- 已完成
- 入组人数
- 2,839
- 试验地点
- 117
- 主要终点
- 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
The purpose of this academic lead study is to determine if a treatment strategy of early intensive blood pressure (BP) lowering compared to conservative BP lowering policy in patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH) improves the outcome of death and disability at 3 months after onset.
详细描述
Intracerebral haemorrhage (ICH) is one of the most serious subtypes of stroke, affecting over a million people worldwide each year, most of whom live in Asia. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Despite the magnitude of the disease burden and cost on healthcare resources, there remains uncertainty about the role of surgery for ICH and no acute medical therapies have been shown to definitely alter outcome in ICH.
The INTERACT2 study follows the recently completed initial pilot study vanguard phase) which established the feasibility of the protocol, safety of early intensive BP lowering, and effects on haematoma expansion within 6 hours of onset of ICH. Having established 'proof-of-concept' that BP lowering may improve outcome by reducing haematoma expansion, INTERACT2 aims to establish the effects of the treatment on major clinical endpoints in patients with ICH recruited from an expanding clinical network around the world.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CT-confirmed spontaneous Intracerebral Haemorrhage (ICH)
- •Elevated systolic blood pressure (>150mmHg and <220mmHg)
- •Capacity to commence randomly assigned treatment within 6 hours of onset of ICH.
- •Able to be 'actively' treated and admitted to a monitored facility
排除标准
- •Clear indication or contraindication to intensive BP lowering.
- •Evidence ICH secondary to a structural abnormality
- •Use of thrombolytic agent
- •Previous ischaemic stroke within 30 days
- •A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
- •Score of 3-5 on the Glasgow Coma Scale (indicating deep coma)
- •Significant pre-stroke disability or advanced dementia
- •Planned early neurological intervention
- •Participation in another clinical trial.
- •A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
研究组 & 干预措施
Intensive BP lowering
Management policy to lower the systolic Blood pressure (BP) to a target of 140mmHg within 1 hour of randomization and sustained for 24 hours. Sites were provided with protocols for different intravenous agents and used whichever routinely available drugs were in their hospital.
干预措施: Blood pressure management policies (Other)
Guideline recommended BP lowering
Patients received management of BP based on the standard guidelines at the time, as published by the American Heart Association (AHA) in 2007 and 2010. The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.
干预措施: Blood pressure management policies (Other)
结局指标
主要结局
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: 90 days
次要结局
- Death at 90 Days(90 days)
研究者
Craig Anderson
Senior Director, Neurological and Mental Health Division
The George Institute