Desmopressin for Reversal of Antiplatelet Drugs in Stroke Due to Haemorrhage (DASH)
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|ClinicalTrials.gov Identifier: NCT03696121|
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : April 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Acute||Drug: Desmopressin Injection Drug: Normal saline||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
Drug: Desmopressin Injection
Single dose 20 micrograms in 50ml Normal Saline as intravenous injection infused over 20 minutes
Placebo Comparator: Control
Drug: Normal saline
Single dose 50ml Normal Saline as intravenous injection infused over 20 minutes
- 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
- 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
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
|Contact: Diane Havard||+44 115 email@example.com|
|Contact: Nikola Sprigg||+44 115 firstname.lastname@example.org|
|Nottingham City Hospital||Recruiting|
|Nottingham, Notts, United Kingdom, NG5 1PB|
|Contact: Nikola Sprigg 1158231765 email@example.com|
|Principal Investigator:||Nikola Sprigg||University of Nottingham|