Desmopressin for Reversal of Antiplatelet Drugs in Stroke Due to Haemorrhage

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

June 8, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

September 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of eligible patients who received allocated treatment[ Time Frame: 90 days ]

Number - higher number indicates feasibility of trial

Number of participants followed up[ Time Frame: 90 Days ]

Number - higher number indicates feasibility of trial

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Hyponatraemia[ Time Frame: 24 hours ]
<135mmol/L
Number of patients dead or suffered serious adverse events[ Time Frame: Day 28 and 90 ]
Number - higher number 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
Modified Rankin scale[ Time Frame: Day 90 ]
Range 0 - 6, with lower scores indicating less disability

Descriptive Information

Brief Title ^ICMJE

Desmopressin for Reversal of Antiplatelet Drugs in Stroke Due to Haemorrhage

Official Title ^ICMJE

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

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Desmopressin Injection
Single dose 20 micrograms in 50ml Normal Saline as intravenous injection infused over 20 minutes
Drug: Normal saline
Single dose 50ml Normal Saline as intravenous injection infused over 20 minutes

Study Arms

Experimental: Intervention
Desmopressin injection
Placebo Comparator: Control
Normal Saline

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 2019

Estimated Primary Completion Date

September 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

16 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

，

Study Sponsor ^ICMJE

University of Nottingham

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Nikola Sprigg University of Nottingham

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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