DRUG
Desmopressin Injection
Single dose 20 micrograms in 50ml Normal Saline as intravenous injection infused over 20 minutes
Desmopressin for Reversal of Antiplatelet Drugs in Stroke Due to Haemorrhage
Status
Completed
Phase
Phase 2
Enrollment
54
Locations
1
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
DRUG
Normal saline
Single dose 50ml Normal Saline as intravenous injection infused over 20 minutes
Timeline
From registration to results.
First posted
Oct 4, 2018
Study start
Apr 1, 2019
Primary completion
Jun 30, 2022
Study completion
Jun 30, 2022
Results posted
Not reported
Registry updated
Nov 15, 2022
Outcomes
What the study measures.
Primary outcomes
Number of eligible patients who received allocated treatment
Time frame · 90 days
Number - higher number indicates feasibility of trial
Rate of eligible patients randomised
Time frame · 18 months
Shorter period of time to recruit number of patients indicates trial is feasibility;e
Proportion of eligible patients and randomised
Time frame · 18 months
Are there sufficient numbers of patients to justify a larger trial
Proportion of participants followed up at 90 days
Time frame · 90 days
Higher number indicates feasibility
Proportion of patients with full outcome data available, and reasons for non-availability
Time frame · 90 days
Higher number indicates feasibility
Proportion of eligible patients approached
Time frame · 18 months
Higher number indicates feasibility
Adherence to intervention
Time frame · 18 months
Higher number indicates feasibility
Secondary outcomes
Death or dependency at 90 days
Time frame · 18 months
Lower number indicates positive outcome
Number of patients dead or suffered serious adverse events
Time frame · Day 28 and 90
Number - higher number indicates worse outcome
Change in intracerebral haemorrhage volume at 24 hours
Time frame · 24 hours
Higher volume indicates worse outcome
Disability - Barthel index
Time frame · Day 90
Scores range from 0 - 100, with lower scores indicating increased disability.
Quality of life - EuroQol
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).
Cognition - telephone MMSE
Time frame · Day 90
Scores are out of 22, with lower scores indicating cognitive impairment
Length of hospital stay
Time frame · Day 90
Number of days - higher number indicates longer length of stay
Discharge destination
Time frame · 18 months
Destination of participant following discharge from hospital
Health Economic assessment (EQ5D)
Time frame · 90 Days
Range 0-100, Higher score indicates better health
Serious adverse events (including thromboembolic events)
Time frame · Day 90
Higher volume indicates worse outcome
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 110 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Study locations
1 registered sites.
United Kingdom. Showing up to 24 locations stored in the fast local snapshot.
Nottingham City Hospital
Nottingham, Notts, United Kingdom
Publications
Results and literature.
PMID 37870112 ↗Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.PMID 33172941 ↗Desborough MJR, Al-Shahi Salman R, Stanworth SJ, Havard D, Brennan PM, Dineen RA, Coats TJ, Hepburn T, Bath PM, Sprigg N. Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH): protocol for a phase II double-blind randomised controlled feasibility trial. BMJ Open. 2020 Nov 10;10(11):e037555. doi: 10.1136/bmjopen-2020-037555.
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