Abstract Background and aims Approximately one quarter of patients with ICH are in people taking antiplatelet drugs. Data from the TICH-2 trial suggest the odds of death or disability to be increased by 67% for patients taking antiplatelet drugs. A therapy such as desmopressin to reverse the effects of antiplatelet drugs in ICH requires evaluation. Methods To assess whether desmopressin reduces death or disability for patients with ICH who are taking antiplatelet drugs. Results DASH-2 is a phase III single blind ended point randomised placebo-controlled efficacy trial, delivered by the addition of an additional intervention and comparison, nested within the master protocol of the ongoing pragmatic phase III prospective randomised TICH-3 RCT. If the patient is eligible for both tranexamic acid and desmopressin comparisons, they may be enrolled into both comparisons in a partial factorial design. 1000 adults with acute (24 hours) intracerebral haemorrhage, taking antiplatelet drugs from an estimated 65 UK sites will be randomised (1:1) to receive either intravenous desmopressin (20μg in 50 ml Sodium Chloride 0.9% infused over 20 minutes.) or matching placebo (Sodium Chloride 0.9%) via an identical regime. Standard pharmacy supplies of the IMP will be used. Patients, relatives, and outcome assessors will be masked to treatment allocation. Blinded central follow-up will minimise performance and detection bias. Conclusions Ordinal shift in modified Rankin scale will be assessed as the primary outcome using an intention-to-treat population as well as pre-specified subgroups. Secondary outcomes will assess safety, functional and cognitive outcome’s and health economics. Conflict of interest
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Nikola Sprigg
Michael Desborough
Philip Bath
European Stroke Journal
University of Oxford
University College London
University of Edinburgh
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Sprigg et al. (Fri,) studied this question.
www.synapsesocial.com/papers/69fd7e5cbfa21ec5bbf0688d — DOI: https://doi.org/10.1093/esj/aakag023.2011