Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03696121
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Nottingham

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.

Condition or disease Intervention/treatment Phase
Stroke, Acute Drug: Desmopressin Injection Drug: Normal saline Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Desmopressin for Reversal of Antiplatelet Drugs in Stroke Due to Haemorrhage (DASH)
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Desmopressin injection
Drug: Desmopressin Injection
Single dose 20 micrograms in 50ml Normal Saline as intravenous injection infused over 20 minutes

Placebo Comparator: Control
Normal Saline
Drug: Normal saline
Single dose 50ml Normal Saline as intravenous injection infused over 20 minutes




Primary Outcome Measures :
  1. Number of eligible patients who received allocated treatment [ Time Frame: 90 days ]
    Number - higher number indicates feasibility of trial

  2. Number of participants followed up [ Time Frame: 90 Days ]
    Number - higher number indicates feasibility of trial


Secondary Outcome Measures :
  1. Hyponatraemia [ Time Frame: 24 hours ]
    <135mmol/L

  2. Number of patients dead or suffered serious adverse events [ Time Frame: Day 28 and 90 ]
    Number - higher number indicates worse outcome

  3. Disability - Barthel index [ Time Frame: Day 90 ]
    Scores range from 0 - 100, with lower scores indicating increased disability.

  4. 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).


  5. Cognition - telephone MMSE [ Time Frame: Day 90 ]
    Scores are out of 22, with lower scores indicating cognitive impairment

  6. Length of hospital stay [ Time Frame: Day 90 ]
    Number of days - higher number indicates longer length of stay

  7. Modified Rankin scale [ Time Frame: Day 90 ]
    Range 0 - 6, with lower scores indicating less disability



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 110 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (≥16 years)
  • Confirmed intracerebral haemorrhage on imaging
  • Less than 12 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696121


Contacts
Layout table for location contacts
Contact: Diane Havard +44 115 8231775 diane.havard@nottingham.ac.uk
Contact: Nikola Sprigg +44 115 8231778 nikola.sprigg@nottingham.ac.uk

Locations
Layout table for location information
United Kingdom
Nottingham City Hospital Recruiting
Nottingham, Notts, United Kingdom, NG5 1PB
Contact: Nikola Sprigg    1158231765    nikola.sprigg@nottingham.ac.uk   
Sponsors and Collaborators
University of Nottingham
National Institute for Health Research, United Kingdom
Investigators
Layout table for investigator information
Principal Investigator: Nikola Sprigg University of Nottingham

Layout table for additonal information
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03696121     History of Changes
Other Study ID Numbers: 18040
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Nottingham:
intracerebral haemorrhage

Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Deamino Arginine Vasopressin
Platelet Aggregation Inhibitors
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs