Nottingham City Hospital
Nottingham, Notts, NG5 1PB, United Kingdom
NCT Number: NCT03696121
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.
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Notify Me18 year–110 year
All sexes
Interventional
Phase 2
Nottingham, Notts, NG5 1PB, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 90 days
Number - higher number indicates feasibility of trial
Time frame: 18 months
Shorter period of time to recruit number of patients indicates trial is feasibility;e
Time frame: 18 months
Are there sufficient numbers of patients to justify a larger trial
Time frame: 90 days
Higher number indicates feasibility
Time frame: 90 days
Higher number indicates feasibility
Time frame: 18 months
Higher number indicates feasibility
Time frame: 18 months
Higher number indicates feasibility
Time frame: 18 months
Lower number indicates positive outcome
Time frame: Day 28 and 90
Number - higher number indicates worse outcome
Time frame: 24 hours
Higher volume indicates worse outcome
Time frame: Day 90
Scores range from 0 - 100, with lower scores indicating increased disability.
Time frame: Day 90
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
Scores are out of 22, with lower scores indicating cognitive impairment
Time frame: Day 90
Number of days - higher number indicates longer length of stay
Time frame: 18 months
Destination of participant following discharge from hospital
Time frame: 90 Days
Range 0-100, Higher score indicates better health
Time frame: Day 90
Higher volume indicates worse outcome
Time frame: One hour post administration of Desmopressin
University of Nottingham
Other
Desmopressin for Reversal of Antiplatelet Drugs in Stroke Due to Haemorrhage (DASH)
Acronym: DASH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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