Brain Infarct Clinical Trial
Official title:
Safety and Efficacy of Immediate Normal Saline Infusion for Stroke After Intravenous Thrombolysis (NS-STAR): a Protocol of Randomized Controlled Trial
This study aims to explore the safety and efficacy of 0.9% normal saline （NS） infusion on stroke after intravenous thrombolysis (IVT), we decided to conduct this multi-centre randomized controlled trial for the first time. This trial will provide an innovative strategy to facilitate functional independence after stroke administered with IVT. This is a multi-center, randomized controlled two arm (1:1 ratio) clinical trial. The enrolled participators will be divided into NS group and control group randomly after confirming as acute ischemic stroke (AIS) according to symptoms and signs. In NS group, the patient will undergo NS 2000ml intravenous infusion swiftly after IVT, with the speed of 200ml/h. In control group, the patient will not undergo NS intravenous infusion after IVT. The primary efficacy is disability at days 90, as scored by means of the modified Rankin scale (mRS), dichotomized as a favorable outcome (a score of 0 or 1), or an unfavorable outcome (a score of 2 to 6). The secondary outcomes mainly comprise neurological deficits, disability, imaging and laboratory tests at each follow-up time. The safety outcomes include the cerebral edema at 24-hour post-IVT detected by cranial CT, the 24-hour fluctuation of blood pressure and the cardiac function detected by ultrasonic cardiogram within 3 days after IVT. Stata 15.1 and R software will be used for statistical analysis
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