Bache Kristi G, Hov Maren Ranhoff, Larsen Karianne, Solyga Volker Moræus, Lund Christian G
Research and Development, The Norwegian Air Ambulance Foundation, Drøbak, Norway.
Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.
JMIR Res Protoc. 2018 Feb 28;7(2):e53. doi: 10.2196/resprot.8110.
Acute ischemic stroke (AIS) is a medical emergency. The outcome is closely linked to the time elapsing from symptom onset to treatment, and seemingly small delays can mean the difference between full recovery and physical and cognitive dysfunction. Recanalization to allow blood to reenter the affected area is most efficient immediately after symptoms occur, and intravenous thrombolysis must be initiated no later than 4.5 hours after the symptom onset. A liable diagnosis is mandatory to administer the appropriate treatment. Prehospital diagnosis and, in cases where contraindications are ruled out, prehospital initiation of intravenous thrombolysis have been shown to significantly decrease the time from alarm to the treatment.
The objective of this paper is to investigate the effectiveness of prehospital thrombolysis as measured by (1) time spent from symptom onset to treatment and (2) the number of patients treated within 4.5 hours. In addition, we want to conduct explorative studies. These will include (1) the use of biomarkers for diagnostic and prognostic use where we will collect blood samples from various time points, including the hyperacute phase and (2) the study of magnetic resonance imaging (MRI) images at day 1 to determine the infarct volume and if the time to thrombolysis has an influence on this.
This is a prospective controlled intervention study. The intervention will involve a computed tomography (CT) and thrombolysis in a physician-manned ambulance called a mobile stroke unit (MSU). The control will be the conventional pathway where the patient is transported to the hospital for CT, and thrombolysis as per current procedure.
Patient inclusion has started and a total of 37 patients are enrolled (control and intervention combined). The estimated time to completed inclusion is 36 months, starting from May 2017. The results of this study will be analyzed and published at the end of the trial.
This trial aims to document the feasibility of saving time for all stroke patients by providing prehospital diagnostics and treatment, as well as transport to appropriate level of care, in a safe environment provided by anesthesiologists trained in prehospital critical care.
ClinicalTrials.gov NCT03158259; https://clinicaltrials.gov/show/NCT03158259 (Archived by WebCite at http://www.webcitation.org/6wxNEUMUD).
急性缺血性卒中（AIS）是一种医疗急症。其预后与症状发作到治疗的时间密切相关，看似微小的延误可能意味着完全康复与身体及认知功能障碍之间的差异。症状出现后立即进行再通以使血液重新进入受影响区域最为有效，静脉溶栓必须在症状发作后不迟于4.5小时启动。做出可靠的诊断对于给予恰当治疗至关重要。已证明院前诊断以及在排除禁忌证的情况下院前启动静脉溶栓可显著缩短从报警到治疗的时间。
本文的目的是通过以下指标研究院前溶栓的有效性：（1）从症状发作到治疗所花费的时间；（2）在4.5小时内接受治疗的患者数量。此外，我们希望进行探索性研究。这些研究将包括：（1）使用生物标志物进行诊断和预后评估，我们将在包括超急性期在内的各个时间点采集血样；（2）在第1天研究磁共振成像（MRI）图像以确定梗死体积，以及溶栓时间是否对此有影响。
这是一项前瞻性对照干预研究。干预措施将包括在配备医生的救护车（称为移动卒中单元，MSU）中进行计算机断层扫描（CT）和溶栓。对照组为常规流程，即患者被送往医院进行CT检查，并按照当前程序进行溶栓。
患者纳入工作已开始，共纳入37例患者（对照组和干预组合并）。从2017年5月开始，预计完成纳入的时间为36个月。本研究结果将在试验结束时进行分析和发表。
本试验旨在证明在经过院前重症监护培训的麻醉医生提供的安全环境中，通过提供院前诊断、治疗以及转运至适当的护理水平，为所有卒中患者节省时间的可行性。
ClinicalTrials.gov NCT03158259；https://clinicaltrials.gov/show/NCT03158259（由WebCite存档于http://www.webcitation.org/6wxNEUMUD）
