Association of Prophylactic Use of Stress Ulcer Drugs and Clinical Outcomes in Patients With Acute Anterior Circulation Thrombectomy: a Prospective, Multicenter, Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,592
- 试验地点
- 19
- 主要终点
- 90-day mortality after onset
研究概览
简要总结
Ischemic stroke accounts for a relatively high proportion of strokes. In recent years, intravenous thrombolysis and endovascular therapy have significantly improved the revascularization rate in patients with large vessel occlusive cerebral infarction, but 20-50% of patients still experience ineffective revascularization. Therefore, postoperative monitoring and treatment of patients with large vessel occlusions is crucial for early recognition, management and prevention of complications. Stress ulcer bleeding is a serious complication after acute ischemic stroke, with a prevalence of 1%-5%, and a previously proven incidence of stress ulcer bleeding after ischemic stroke. Stress ulcer bleeding after ischemic stroke has been shown to be closely associated with unfavorable outcomes, such as mortality. Current national and international guidelines or consensus on the prevention of stress ulcers after acute ischemic stroke do not advocate the routine use of histamine receptor antagonists or proton pump inhibitors for the prevention of stress ulcers, but rather should be considered in the context of the patient's risk factors for stress ulcers and discontinued after the patient initiates enteral nutrition. However, there is no evidence-based medical evidence to support the risk-benefit relationship of stress ulcer drug prophylaxis in patients with mechanical thrombectomy for acute anterior circulation large vessel occlusion.
详细描述
Stress ulcer bleeding is a serious complication after acute ischemic stroke, with a prevalence of 1%-5%, of which only 0.5%-1% require blood transfusion or result in hypotension. Stress ulcer bleeding after ischemic stroke has been shown to be associated with poor outcomes, such as mortality, and basilar artery occlusion and middle cerebral artery cerebral infarction are independent risk factors for stress ulcer bleeding after acute ischemic stroke. Guidelines or consensus on the prevention of stress ulcers after acute ischemic stroke do not advocate the routine use of histamine receptor antagonists or proton pump inhibitors for stress ulcer prevention.
However, stress ulcer prophylaxis is initiated in most patients admitted to the neurological intensive care unit after mechanical embolization of acute anterior circulation large vessel occlusion. With advances such as diagnosis and early initiation of enteral nutrition, the rate of stress ulcer bleeding in patients with mechanical embolization of acute anterior circulation large vessel occlusion is significantly reduced. The relationship between the risk and benefit of SUP in patients undergoing mechanical embolization for acute anterior circulation large vessel occlusion is not yet supported by evidence-based medical evidence. Therefore, the purpose of this study was to investigate the correlation between pharmacological stress ulcer prophylaxis and clinical outcomes in patients undergoing mechanical thrombectomy for acute anterior circulation large vessel occlusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Within 24 hours of onset. Meet the criteria for diagnosis of acute ischemic stroke in the "China Acute Ischemic Stroke Diagnosis and Treatment Guidelines 2018".
- •Meet the indications for mechanical thrombectomy in the "Chinese Guidelines for Early Endovascular Interventions in Acute Ischemic Stroke 2022".
- •Treated with mechanical thrombectomy.
- •NIHSS score ≥ 6 at onset of illness.
- •Sign an informed notice.
排除标准
- •Allergy to drug ingredients. Women who are pregnant or breastfeeding. Life expectancy of less than 3 months due to other non-ischemic stroke diseases such as malignancy, severe liver or renal failure.
- •Have participated in other interventional clinical studies (affecting the outcome of this cohort study).
- •Participants who were judged by the investigator to be unsuitable for participation in this study.
结局指标
主要结局
90-day mortality after onset
时间窗: 90-day after onset
Proportion of enrolled patients who died 90 days after onset of disease.
Incidence of stroke-associated pneumonia
时间窗: within 7-day of onset
Incidence of non-mechanically ventilated stroke patients with new pneumonia within 7-day of onset
次要结局
- Incidence of clinically significant bleeding(within 7-day of onset)
- Incidence of stress ulcer bleeding(7-day after onset)
- Incidence of unfavorable functional prognosis at 90 days after onset(90-day after onset)
- 90-day mRS score change(90-day after onset)
- Incidence of early neurological deterioration(within 72 hours after onset)
- 1-year post-onset mortality(1 year after onset)
- Incidence of adverse related events such as pneumonia or myocardial ischemia 1 year after onset(1 year after onset)