Clinical Trials Directory

Trials / Completed

CompletedNCT03696121

Desmopressin for Reversal of Antiplatelet Drugs in Stroke Due to Haemorrhage

Desmopressin for Reversal of Antiplatelet Drugs in Stroke Due to Haemorrhage (DASH)

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
54 (actual)
Sponsor
University of Nottingham · Academic / Other
Sex
All
Age
18 Years – 110 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGDesmopressin InjectionSingle dose 20 micrograms in 50ml Normal Saline as intravenous injection infused over 20 minutes
DRUGNormal salineSingle dose 50ml Normal Saline as intravenous injection infused over 20 minutes

Timeline

Start date
2019-04-01
Primary completion
2022-06-30
Completion
2022-06-30
First posted
2018-10-04
Last updated
2022-11-15

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03696121. Inclusion in this directory is not an endorsement.