Clinical Study of Fructose Injection in the Treatment of Acute Ischemic Stroke
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
- 试验地点
- 1
研究概览
简要总结
This is a single-center, prospective, randomized, open-label, blinded-endpoint exploratory clinical study enrolling 46 patients with acute ischemic stroke. All eligible patients have symptom onset within 4.5 hours, meet intravenous thrombolysis indications, and receive standard thrombolysis and routine stroke treatment. Participants are randomly assigned to two groups: the intervention group receives early intravenous infusion of 10% fructose injection plus standard treatment, while the control group receives only standard treatment without fructose. The study mainly evaluates changes in neurological function via NIHSS scores within 7 days after thrombolysis, assesses cerebral infarct lesion volume and brain edema using multimodal MRI including DWI, T2WI and MRS, detects cerebral neuronal metabolic markers, and conducts 1-month follow-up of neurological function by NIHSS score as well as functional prognosis using the mRS score. The research also comprehensively monitors adverse events and safety indicators to explore the clinical efficacy, neuronal metabolic regulation effect and safety of early fructose injection combined with intravenous thrombolysis in acute ischemic stroke patients, aiming to provide clinical evidence for early neuroprotective intervention.
详细描述
This is an investigator-initiated, single-center, prospective, randomized, open-label, blinded-endpoint (PROBE) exploratory clinical trial. A total of 46 eligible patients with acute ischemic stroke within 4.5 hours of onset who meet the indications for intravenous thrombolysis will be enrolled. Participants are randomly assigned to an intervention group and a control group.The intervention group receives early intravenous infusion of 250 mL 10% fructose injection combined with standard intravenous thrombolysis and routine stroke background treatment. The control group receives only standard intravenous thrombolysis and conventional medical therapy without fructose intervention. All patients undergo standardized blood pressure and blood glucose management, and antiplatelet therapy is initiated 24 hours after thrombolysis.Neurological function is repeatedly assessed using the National Institutes of Health Stroke Scale (NIHSS) every 12 hours within 72 hours after thrombolysis and daily thereafter. Multimodal brain magnetic resonance examinations including DWI, T2WI and MRS are performed to evaluate cerebral infarct lesion volume, cerebral edema, and neuronal metabolic biomarkers such as NAA, Cho and Lac. The primary outcome is the change in NIHSS score at 7 days after thrombolysis, and cerebral neuronal metabolic characteristics. Secondary outcomes include dynamic neurological recovery, imaging changes of ischemic lesions, 1-month NIHSS score, 1-month modified Rankin Scale (mRS) functional prognosis.Prespecified subgroup analyses are conducted according to baseline neurological deficit severity, age, hypertension history and gender. Safety outcomes monitor adverse events such as hemorrhagic transformation, allergic reactions, liver and renal function abnormalities, blood glucose and electrolyte disorders to evaluate the clinical safety and tolerability of early fructose combined with thrombolysis.An independent clinical endpoint adjudication committee blindly assesses all endpoint events to reduce evaluation bias. Statistical analyses adopt appropriate methods for non-equilibrium small sample data to explore the clinical efficacy, neuronal mitochondrial metabolic regulation mechanism and safety of early fructose injection intervention in acute ischemic stroke patients, so as to provide clinical evidence for early neuroprotective strategy optimization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is an open-label trial with blinded endpoint assessment (PROBE design). Participants, care providers and study investigators are unblinded to group allocation. All clinical endpoint events, NIHSS and mRS evaluations, and imaging metabolic assessments are independently adjudicated by a blinded endpoint adjudication committee who remain unaware of patient treatment assignment throughout the study to avoid assessment bias.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 85 years, male and female are both eligible.
- •Clinical diagnosis of acute ischemic stroke meeting the diagnostic criteria of Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke.
- •Time from stroke onset to hospital admission ≤ 4.5 hours, with new ischemic lesions confirmed by emergency multimodal cranial MRI (DWI/T2WI).
- •Meeting the indications for intravenous thrombolysis, without absolute contraindications to thrombolysis, and planned to receive standard intravenous thrombolysis.
- •Relatively stable vital signs, able to complete baseline and follow-up cranial MRI examinations including DWI, T2WI and ¹H-MRS, as well as NIHSS and mRS scale assessments.
- •The patient or legal representative voluntarily participates in the study and signs written informed consent.
排除标准
- •History of fructose intolerance, abnormal fructose metabolism or hereditary fructose metabolic disorders.
- •History of diabetes mellitus or random blood glucose > 11.1 mmol/L.
- •Evidence of intracranial hemorrhage on CT scan, symptomatic intracranial hemorrhage, or clinical suspicion of subarachnoid hemorrhage.
- •Requiring or intending to continue using restricted medications that may interfere with study safety and implementation.
- •Unable to complete cranial MRI examination due to implanted metal materials, claustrophobia or other reasons.
- •Any other conditions judged by the investigator to be inappropriate for enrollment.
- •Presence of hemorrhagic diathesis, including but not limited to:
- •Known hereditary bleeding tendency or severe bleeding disease within the past 6 months;
- •Received heparin within 48 hours before enrollment with aPTT exceeding the upper limit of laboratory reference range;
- •Current use of vitamin K-dependent oral anticoagulants with INR > 1.7 or PT > 15 s, or current use of novel oral anticoagulants with prolonged aPTT/PT above laboratory upper limit;
- •Platelet count < 100,000/mm³ at screening;
- •History of central nervous system diseases such as tumor, aneurysm, intracranial or spinal surgery;
- •Received traumatic closed-chest cardiac massage, obstetric delivery or non-compressible vascular puncture within the past 10 days;
- •Suspected intracranial hemorrhage or aneurysmal subarachnoid hemorrhage;
- •Tumors with increased bleeding risk;
- •Peptic ulcer disease, esophageal varices, aneurysm, arterial/venous malformation within the past 3 months;
- •Any other known diseases associated with significantly elevated bleeding risk.
- •Pre-stroke mRS score ≥ 2, combined with dementia or other neurological disabling diseases.
- •Complicated with severe medical history affecting endpoint evaluation and follow-up, such as craniocerebral trauma, multiple sclerosis, encephalitis, tumor, poisoning, syphilis, or severe cardiac, pulmonary, hepatic, renal and endocrine diseases.
- •Pregnant females.
- •Currently participating in another investigational drug or device study, or participation in other experimental treatment within less than 30 days prior to enrollment.
- •Combined with severe hepatic and renal insufficiency (eGFR < 30 mL/min/1.73m²).
- •Refusal to sign informed consent.
研究组 & 干预措施
Standard Thrombolysis Alone Without Fructose
Patients receive only standard intravenous thrombolysis and routine standardized medical treatment for acute ischemic stroke without additional fructose injection. All participants receive the same unified blood pressure, blood glucose control and antiplatelet therapy regimen as the intervention group.
Fructose Injection plus Standard Thrombolysis Treatment
Patients receive early intravenous infusion of 250 mL 10% fructose injection immediately after admission, followed by standard intravenous thrombolysis and routine standardized medical treatment for acute ischemic stroke. Unified blood pressure and blood glucose management are performed in all participants, and antiplatelet therapy is initiated 24 hours after thrombolysis.
干预措施: 10% Fructose Injection (Drug)
研究者
Ji Xunming,MD,PhD
professor
Capital Medical University