Desmopressin for Reversal of Antiplatelet Drugs in Stroke Due to Haemorrhage (DASH)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Proportion of eligible patients approached
研究概览
简要总结
Haemorrhagic stroke, an emergency caused by bleeding in the brain, often leads to death or long-term disability. A quarter of these patients are taking blood-thinning drugs (antiplatelet drugs, such as aspirin) because they are at risk of a heart attack or ischaemic stroke. Patients taking these drugs are more likely to die or be disabled if they have a haemorrhagic stroke. At present, there is no effective treatment for reversing their effects. Desmopressin is a drug which may reverse the effects of antiplatelet drugs and stop bleeding. The investigators would like to run a large randomised trial to see if Desmopressin can reduce the number of people who die or are disabled after haemorrhagic stroke.
详细描述
Intracerebral haemorrhage is a medical emergency, caused by a blood vessel bleeding directly into the brain. Outcome is directly related to the amount of bleeding that occurs. Many patients die early and others are left with significant disability. A quarter of all people with intracerebral haemorrhage are taking an antiplatelet drug, which is associated with larger volumes of brain haemorrhage and significantly worse outcomes. Four to five million people are taking antiplatelet drugs in the UK and use continues to rise in an ageing population.
Despite advances in treatment of ischaemic stroke, there is no effective drug treatment for intracerebral haemorrhage. Treatment for intracerebral haemorrhage has been identified as a priority area by Stroke Association and stroke survivors.
Desmopressin is a drug that reverses blood thinning effects of antiplatelet drugs, by indirectly increasing platelet adhesion, which the investigators hypothesise will minimise the devastating consequences of intracerebral haemorrhage associated with antiplatelet drugs. Desmopressin is commonly used in patients with inherited platelet dysfunction disorders and is an appealing treatment for antiplatelet-associated intracerebral haemorrhage. A recent systematic review did not find any randomised controlled trials evaluating desmopressin for antiplatelet-associated intracerebral haemorrhage. Desmopressin is affordable, available and could be implemented clinically across the UK and worldwide in the next five years with immediate benefit for stroke patients, their families and society.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years)
- •Confirmed intracerebral haemorrhage on imaging
- •Less than 24 hours from onset of symptoms [or from when last seen free of stroke symptoms]
- •Prescribed and thought to be taking a daily oral antiplatelet drug in the preceding seven days (cyclooxygenase inhibitors, phosphodiesterase inhibitors or P2Y12 inhibitors)
- •Signed consent (or waiver of consent).
排除标准
- •Aneurysmal subarachnoid haemorrhage known at time of enrolment
- •Haemorrhage suspected to be due to transformation of ischaemic stroke
- •Haemorrhage known to be due to thrombolytic drug
- •Haemorrhage known to be due to venous thrombosis
- •Risk/s of fluid retention associated with desmopressin judged clinically significant by the attending physician (for example patients with pulmonary oedema and/or cardiac failure) - - Significant hypotension (systolic blood pressure <90mmHg)
- •Known drug-eluting coronary artery stent in previous three months
- •Allergy to desmopressin
- •Pregnant or breast-feeding
- •Life expectancy less than four hours, or planned for palliative care only
- •Glasgow coma scale less than 5, mRS >4.
研究组 & 干预措施
Intervention
Desmopressin injection
干预措施: Desmopressin Injection (Drug)
Control
Normal Saline
干预措施: Normal saline (Drug)
结局指标
主要结局
Proportion of eligible patients approached
时间窗: 18 months
Higher number indicates feasibility
Number of eligible patients who received allocated treatment
时间窗: 90 days
Number - higher number indicates feasibility of trial
Rate of eligible patients randomised
时间窗: 18 months
Shorter period of time to recruit number of patients indicates trial is feasibility;e
Adherence to intervention
时间窗: 18 months
Higher number indicates feasibility
Proportion of participants followed up at 90 days
时间窗: 90 days
Higher number indicates feasibility
Proportion of eligible patients and randomised
时间窗: 18 months
Are there sufficient numbers of patients to justify a larger trial
Proportion of patients with full outcome data available, and reasons for non-availability
时间窗: 90 days
Higher number indicates feasibility
次要结局
- Discharge destination(18 months)
- Change in intracerebral haemorrhage volume at 24 hours(24 hours)
- Death or dependency at 90 days(18 months)
- Disability - Barthel index(Day 90)
- Quality of life - EuroQol(Day 90)
- Cognition - telephone MMSE(Day 90)
- Number of patients dead or suffered serious adverse events(Day 28 and 90)
- Length of hospital stay(Day 90)
- Health Economic assessment (EQ5D)(90 Days)
- Serious adverse events (including thromboembolic events)(Day 90)
- Change in factor vIII, Von Willebrand Factor antigen and Von Willebrand Factor activity will be assessed(One hour post administration of Desmopressin)