Desborough Michael J R, Al-Shahi Salman Rustam, Stanworth Simon J, Havard Diane, Brennan Paul M, Dineen Robert A, Coats Timothy J, Hepburn Trish, Bath Philip M, Sprigg Nikola
Haemostasis and Thrombosis Centre, St Thomas' Hospital, London, UK.
Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.
BMJ Open. 2020 Nov 10;10(11):e037555. doi: 10.1136/bmjopen-2020-037555.
Intracerebral haemorrhage (ICH) can be devastating and is a common cause of death and disability worldwide. Pre-ICH antiplatelet drug use is associated with a 27% relative increase in 1 month case fatality compared with patients not using antithrombotic drugs. We aim to assess the feasibility of conducting a randomised controlled testing the safety and efficacy of desmopressin for patients with antiplatelet-associated ICH.
We aim to include 50 patients within 24 hours of spontaneous ICH onset, associated with oral antiplatelet drug(s) use in at least the preceding 7 days. Patients will be randomised (1:1) to receive intravenous desmopressin 20 µg in 50 mL sodium chloride 0.9% infused over 20 min or matching placebo. We will mask participants, relatives and outcome assessors to treatment allocation. Feasibility outcomes include proportion of patients approached being randomised, number of patients receiving allocated treatment, rate of recruitment and adherence to treatment and follow-up. Secondary outcomes include change in ICH volume at 24 hours; hyponatraemia at 24 hours, length of hospital stay, discharge destination, early death less than 28 days, death or dependency at day 90, death up to day 90, serious adverse events (including thromboembolic events) up to day 90; disability (Barthel index, day 90), quality of life (EuroQol 5D (EQ-5D), day 90), cognition (telephone mini-mental state examination day 90) and health economic assessment (EQ-5D).
The Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH) trial received ethical approval from the East Midlands-Nottingham 2 research ethics committee (18/EM/0184). The DASH trial is funded by National Institute for Health and Care Research RfPB grant: PB-PG-0816-20011. Trial results will be published in a peer reviewed academic journal and disseminated through academic conferences and through patient stroke support groups. Reporting will be in compliance with Consolidated Standards of Reporting Trials recommendations.
NCT03696121; ISRCTN67038373; EudraCT 2018-001904-12.
脑出血（ICH）可能具有毁灭性，是全球范围内死亡和残疾的常见原因。与未使用抗血栓药物的患者相比，脑出血前使用抗血小板药物会使1个月内的病死率相对增加27%。我们旨在评估对使用抗血小板药物相关脑出血患者进行去氨加压素安全性和有效性随机对照试验的可行性。
我们的目标是纳入50例自发性脑出血发作24小时内、且至少在之前7天内使用过口服抗血小板药物的患者。患者将被随机分组（1:1），接受在20分钟内静脉输注50mL0.9%氯化钠溶液中含有的20µg去氨加压素，或匹配的安慰剂。我们将对参与者、家属和结果评估者隐瞒治疗分配情况。可行性结果包括被邀请参与随机分组的患者比例、接受分配治疗的患者数量、招募率以及治疗和随访的依从性。次要结果包括24小时时脑出血体积的变化；24小时时的低钠血症、住院时间、出院去向、28天内的早期死亡、90天时的死亡或依赖、90天内的死亡、90天内的严重不良事件（包括血栓栓塞事件）；残疾（Barthel指数，90天）、生活质量（欧洲五维健康量表（EQ-5D），90天）、认知（电话简易精神状态检查，90天）以及卫生经济学评估（EQ-5D）。
用于逆转出血性卒中中抗血小板药物作用的去氨加压素（DASH）试验获得了东米德兰兹-诺丁汉2研究伦理委员会的伦理批准（18/EM/0184）。DASH试验由英国国家健康与照护研究机构的转化与预防拨款资助：PB-PG-0816-20011。试验结果将发表在同行评审的学术期刊上，并通过学术会议和患者卒中支持小组进行传播。报告将符合《报告试验的统一标准》的建议。
NCT03696121；ISRCTN67038373；EudraCT 2018-001904-12。
