Interventional Neuroradiology Department, Hôpital Fondation Adolphe de Rothschild, 29 rue Manin, 75019, Paris, France.
Université Paris-Cité, Paris, France.
Trials. 2022 Jul 26;23(1):598. doi: 10.1186/s13063-022-06538-9.
Hypotension and blood pressure (BP) variability during endovascular therapy (EVT) for acute ischemic stroke (AIS) due to an anterior large vessel occlusion (LVO) is associated with worse outcomes. However, the optimal BP threshold during EVT is still unknown given the lack of randomized controlled evidence. We designed the DETERMINE trial to assess whether an individualized BP management during EVT could achieve better functional outcomes compared to a standard BP management.
The DETERMINE trial is a multicenter, prospective, randomized, controlled, open-label, blinded endpoint clinical trial (PROBE design). AIS patients with a proximal anterior LVO are randomly assigned, in a 1:1 ratio, to an experimental arm in which mean arterial pressure (MAP) is maintained within 10% of the first MAP measured before EVT, or a control arm in which systolic BP (SBP) is maintained within 140-180 mm Hg until reperfusion is achieved or artery closure in case of EVT failure. The primary outcome is the rate of favorable functional outcomes, defined by a modified Rankin Scale (mRS) between 0 and 2 at 90 days. Secondary outcomes include excellent outcome and ordinal analysis of the mRS at 90 days, early neurological improvement at 24 h (National Institutes of Health Stroke Scale), final infarct volume, symptomatic intracranial hemorrhage rates, and all-cause mortality at 90 days. Overall, 432 patients will be included.
DETERMINE will assess the clinical relevance of an individualized BP management before reperfusion compared to the one size fits all approach currently recommended by international guidelines.
ClinicalTrials.gov , NCT04352296. Registered on 20th April 2020.
急性缺血性脑卒中（AIS）患者血管内治疗（EVT）期间发生的低血压和血压变异性与预后不良相关，而前循环大血管闭塞（LVO）所致 AIS 患者更是如此。然而，鉴于缺乏随机对照证据，EVT 期间的最佳血压阈值仍不清楚。我们设计了 DETERMINE 试验，旨在评估与标准血压管理相比，EVT 期间的个体化血压管理是否能获得更好的功能结局。
DETERMINE 试验是一项多中心、前瞻性、随机、对照、开放标签、盲终点临床试验（PROBE 设计）。将具有近端前 LVO 的 AIS 患者以 1:1 的比例随机分配至实验组和对照组，实验组中平均动脉压（MAP）维持在 EVT 前首次测量的 MAP 的 10%以内，对照组中收缩压（SBP）维持在 140-180mmHg 以内，直至再灌注或 EVT 失败时出现动脉闭塞。主要结局是 90 天时改良 Rankin 量表（mRS）评分 0-2 分的良好功能结局发生率。次要结局包括 90 天时 mRS 的优秀结局和有序分析、24 小时时的早期神经改善（国立卫生研究院卒中量表）、最终梗死体积、症状性颅内出血发生率以及 90 天时的全因死亡率。总共将纳入 432 例患者。
DETERMINE 将评估与目前国际指南推荐的一刀切方法相比，再灌注前个体化血压管理的临床相关性。
ClinicalTrials.gov ，NCT04352296。于 2020 年 4 月 20 日注册。
