Desmopressin for Reversal of Antiplatelet Drugs in Stroke Due to Haemorrhage
DASH
1 other identifier
interventional
54
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2018
CompletedFirst Posted
Study publicly available on registry
October 4, 2018
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedNovember 15, 2022
November 1, 2022
3.2 years
June 8, 2018
November 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Number of eligible patients who received allocated treatment
Number - higher number indicates feasibility of trial
90 days
Rate of eligible patients randomised
Shorter period of time to recruit number of patients indicates trial is feasibility;e
18 months
Proportion of eligible patients and randomised
Are there sufficient numbers of patients to justify a larger trial
18 months
Proportion of participants followed up at 90 days
Higher number indicates feasibility
90 days
Proportion of patients with full outcome data available, and reasons for non-availability
Higher number indicates feasibility
90 days
Proportion of eligible patients approached
Higher number indicates feasibility
18 months
Adherence to intervention
Higher number indicates feasibility
18 months
Secondary Outcomes (11)
Death or dependency at 90 days
18 months
Number of patients dead or suffered serious adverse events
Day 28 and 90
Change in intracerebral haemorrhage volume at 24 hours
24 hours
Disability - Barthel index
Day 90
Quality of life - EuroQol
Day 90
- +6 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALDesmopressin injection
Control
PLACEBO COMPARATORNormal Saline
Interventions
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
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nottingham City Hospital
Nottingham, Notts, NG5 1PB, United Kingdom
Related Publications (2)
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: 37870112DERIVEDDesborough 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.
PMID: 33172941DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nikola Sprigg
University of Nottingham
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2018
First Posted
October 4, 2018
Study Start
April 1, 2019
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
November 15, 2022
Record last verified: 2022-11