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Completed

NCT Number: NCT03696121

Desmopressin for Reversal of Antiplatelet Drugs in Stroke Due to Haemorrhage

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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Key information

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nottingham City Hospital

Nottingham, Notts, NG5 1PB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Desmopressin Injection

Drug

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

normal saline

Drug

Single dose 50ml Normal Saline as intravenous injection infused over 20 minutes

Primary outcomes

  1. Number of eligible patients who received allocated treatment

    Time frame: 90 days

    Number - higher number indicates feasibility of trial

  2. Rate of eligible patients randomised

    Time frame: 18 months

    Shorter period of time to recruit number of patients indicates trial is feasibility;e

  3. Proportion of eligible patients and randomised

    Time frame: 18 months

    Are there sufficient numbers of patients to justify a larger trial

  4. Proportion of participants followed up at 90 days

    Time frame: 90 days

    Higher number indicates feasibility

  5. Proportion of patients with full outcome data available, and reasons for non-availability

    Time frame: 90 days

    Higher number indicates feasibility

  6. Proportion of eligible patients approached

    Time frame: 18 months

    Higher number indicates feasibility

  7. Adherence to intervention

    Time frame: 18 months

    Higher number indicates feasibility

Secondary outcomes

  1. Death or dependency at 90 days

    Time frame: 18 months

    Lower number indicates positive outcome

  2. Number of patients dead or suffered serious adverse events

    Time frame: Day 28 and 90

    Number - higher number indicates worse outcome

  3. Change in intracerebral haemorrhage volume at 24 hours

    Time frame: 24 hours

    Higher volume indicates worse outcome

  4. Disability - Barthel index

    Time frame: Day 90

    Scores range from 0 - 100, with lower scores indicating increased disability.

  5. 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).

  6. Cognition - telephone MMSE

    Time frame: Day 90

    Scores are out of 22, with lower scores indicating cognitive impairment

  7. Length of hospital stay

    Time frame: Day 90

    Number of days - higher number indicates longer length of stay

  8. Discharge destination

    Time frame: 18 months

    Destination of participant following discharge from hospital

  9. Health Economic assessment (EQ5D)

    Time frame: 90 Days

    Range 0-100, Higher score indicates better health

  10. Serious adverse events (including thromboembolic events)

    Time frame: Day 90

    Higher volume indicates worse outcome

  11. Change in factor vIII, Von Willebrand Factor antigen and Von Willebrand Factor activity will be assessed

    Time frame: One hour post administration of Desmopressin

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study title

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

Acronym: DASH

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 4, 2018
Registry last updated
Nov 15, 2022

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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