Stroke, AcutePhase 2DASHNCT03696121

Desmopressin for Reversal of Antiplatelet Drugs in Stroke Due to Haemorrhage

A Phase 2 study testing Desmopressin Injection and Normal saline in people with Stroke, Acute, run by University of Nottingham at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 110 years
Conditions the study is for: Stroke, Acute
What is being tested?: Desmopressin Injection and Normal saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Apr 2019to 30 Jun 2022
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 110 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Nottingham City Hospital
Nottingham, Notts, NG5 1PB

Other trials in United Kingdom

About this study

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

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.

Read the 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: Stroke, Acute
Being tested: Desmopressin Injection, Normal saline
Keywords: intracerebral haemorrhage
Medical subject headings: Stroke, Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Desmopressin InjectionDrug
Single dose 20 micrograms in 50ml Normal Saline as intravenous injection infused over 20 minutes
Normal salineDrug
Single dose 50ml Normal Saline as intravenous injection infused over 20 minutes

Study groups in NCT03696121
Study group	Role	What they receive
Intervention	Experimental	Desmopressin injection Receives: Drug: Desmopressin Injection
Control	Placebo comparator	Normal Saline Receives: Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of eligible patients who received allocated treatment
Number - higher number indicates feasibility of trial
Measured: 90 days
Rate of eligible patients randomised
Shorter period of time to recruit number of patients indicates trial is feasibility;e
Measured: 18 months
Proportion of eligible patients and randomised
Are there sufficient numbers of patients to justify a larger trial
Measured: 18 months
Proportion of participants followed up at 90 days
Higher number indicates feasibility
Measured: 90 days
Proportion of patients with full outcome data available, and reasons for non-availability
Higher number indicates feasibility
Measured: 90 days
Proportion of eligible patients approached
Higher number indicates feasibility
Measured: 18 months
Adherence to intervention
Higher number indicates feasibility
Measured: 18 months

Secondary outcomes (11)

Death or dependency at 90 days
Lower number indicates positive outcome
Measured: 18 months
Number of patients dead or suffered serious adverse events
Number - higher number indicates worse outcome
Measured: Day 28 and 90
Change in intracerebral haemorrhage volume at 24 hours
Higher volume indicates worse outcome
Measured: 24 hours
Disability - Barthel index
Scores range from 0 - 100, with lower scores indicating increased disability.
Measured: 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).
Measured: Day 90
Cognition - telephone MMSE
Scores are out of 22, with lower scores indicating cognitive impairment
Measured: Day 90
Length of hospital stay
Number of days - higher number indicates longer length of stay
Measured: Day 90
Discharge destination
Destination of participant following discharge from hospital
Measured: 18 months
Health Economic assessment (EQ5D)
Range 0-100, Higher score indicates better health
Measured: 90 Days
Serious adverse events (including thromboembolic events)
Higher volume indicates worse outcome
Measured: Day 90
Change in factor vIII, Von Willebrand Factor antigen and Von Willebrand Factor activity will be assessed
Measured: One hour post administration of Desmopressin

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201930 Jun 2022

First posted4 Oct 2018
Study start1 Apr 2019
Primary completion30 Jun 2022
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Stroke, AcuteStudies of the same condition, open and under way.
More trials run by University of NottinghamThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03696121
Sponsor's protocol ID: 18040
Acronym: DASH
Status last verified: Nov 2022
First submitted: 8 Jun 2018
Last updated: 15 Nov 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 37870112
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.
PubMed 33172941

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Desmopressin for Reversal of Antiplatelet Drugs in Stroke Due to Haemorrhage (DASH)
ClinicalTrials.gov ID: NCT03696121
Acronym / sponsor ID: DASH / 18040
Conditions: Stroke, Acute
Keywords: intracerebral haemorrhage
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: University of NottinghamUniversity, hospital or other
Collaborators: National Institute for Health Research, United Kingdom
Study start: 1 Apr 2019 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 4 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Drug: Desmopressin InjectionDesmopressin injection
Control	Placebo comparator	Drug: Normal salineNormal Saline

Who may qualify

Ages: 18 to 110 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (10 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Desmopressin InjectionSingle dose 20 micrograms in 50ml Normal Saline as intravenous injection infused over 20 minutes	Drug	Intervention
Normal salineSingle dose 50ml Normal Saline as intravenous injection infused over 20 minutes	Drug	Control

Primary outcome

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

11 secondary outcomes

Death or dependency at 90 days
Time frame: 18 months
Number of patients dead or suffered serious adverse events
Time frame: Day 28 and 90
Change in intracerebral haemorrhage volume at 24 hours
Time frame: 24 hours
Disability - Barthel index
Time frame: Day 90
Quality of life - EuroQol
Time frame: Day 90
Cognition - telephone MMSE
Time frame: Day 90
Length of hospital stay
Time frame: Day 90
Discharge destination
Time frame: 18 months
Health Economic assessment (EQ5D)
Time frame: 90 Days
Serious adverse events (including thromboembolic events)
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
Derived from this study: PubMed 37870112Eilertsen 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.
Derived from this study: PubMed 33172941Desborough 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.
Individual participant dataSharing planned: Undecided

Related trials for Stroke, Acute

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RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nikola Sprigg principal investigator

University of Nottingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Desmopressin Injection and Normal saline in people with Stroke, Acute, run by University of Nottingham at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of eligible patients who received allocated treatment (time frame: 90 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03696121, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.