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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
54
Single dose 20 micrograms in 50ml Normal Saline as intravenous injection infused over 20 minutes
Single dose 50ml Normal Saline as intravenous injection infused over 20 minutes
Nottingham City Hospital
Nottingham, Notts, United Kingdom
Number of eligible patients who received allocated treatment
Number - higher number indicates feasibility of trial
Time frame: 90 days
Rate of eligible patients randomised
Shorter period of time to recruit number of patients indicates trial is feasibility;e
Time frame: 18 months
Proportion of eligible patients and randomised
Are there sufficient numbers of patients to justify a larger trial
Time frame: 18 months
Proportion of participants followed up at 90 days
Higher number indicates feasibility
Time frame: 90 days
Proportion of patients with full outcome data available, and reasons for non-availability
Higher number indicates feasibility
Time frame: 90 days
Proportion of eligible patients approached
Higher number indicates feasibility
Time frame: 18 months
Adherence to intervention
Higher number indicates feasibility
Time frame: 18 months
Death or dependency at 90 days
Lower number indicates positive outcome
Time frame: 18 months
Number of patients dead or suffered serious adverse events
Number - higher number indicates worse outcome
Time frame: Day 28 and 90
Change in intracerebral haemorrhage volume at 24 hours
Higher volume indicates worse outcome
Time frame: 24 hours
Disability - Barthel index
Scores range from 0 - 100, with lower scores indicating increased disability.
Time frame: Day 90
Quality of life - EuroQol
Consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part 1 consists of 5 single-item dimensions. Scores range from 5 - 15 with lower scores indicating no problems to higher scores indicating extreme problems. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state (0) to best imaginable health state (100).
Time frame: Day 90
Cognition - telephone MMSE
Scores are out of 22, with lower scores indicating cognitive impairment
Time frame: Day 90
Length of hospital stay
Number of days - higher number indicates longer length of stay
Time frame: Day 90
Discharge destination
Destination of participant following discharge from hospital
Time frame: 18 months
Health Economic assessment (EQ5D)
Range 0-100, Higher score indicates better health
Time frame: 90 Days
Serious adverse events (including thromboembolic events)
Higher volume indicates worse outcome
Time frame: Day 90
Change in factor vIII, Von Willebrand Factor antigen and Von Willebrand Factor activity will be assessed
Time frame: One hour post administration of Desmopressin
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