NCT06443905进行中（未招募）不适用
Efficacy, Safety and Cost-effectiveness of Xueshuantong Injection (Lyophilized) in the Prevention of Venous Thromboembolism (VTE) in Hospitalized Patients at Risk of Bleeding: a Real-world Cohort Study
China-Japan Friendship Hospital14 个研究点 分布在 1 个国家目标入组 21,600 人开始时间: 2023年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 21,600
- 试验地点
- 14
- 主要终点
- Incidence of VTE
研究概览
简要总结
The purpose of this study is to explore the efficacy, safety and cost-effectiveness of Xueshuantong (lyophilized) for the prevention of venous thromboembolism (VTE) in patients at risk of bleeding.
详细描述
This is a non-randomized, observational study.
This study primarily aims to investigate the efficacy, safety, and cost-effectiveness of using Xueshuantong injection (lyophilized) for preventing venous thromboembolism (VTE) in patients susceptible to bleeding. The subjects of the study comprise patients during the perioperative period (undergoing procedures lasting 45 minutes or longer), patients with a confirmed spontaneous cerebral hemorrhage (ICH), and patients with a confirmed acute ischemic stroke (AIS).
Additional objectives of this study including:
- to evaluate the possible dose-dependency of Xueshuantong injection (lyophilized);
- to evaluate the impact in coagulation function after administration of Xueshuantong injection (lyophilized)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Men or women of ≥18 year old;
- •Hospitalized between Jan 1, 2016 and Aug. 1, 2023;
- •Received intravenous (IV) Xueshuantong (lyophilized) for ≥3 days;
- •Who also meet one of the following criteria:
- •Perioperative patients:
- •Performed any of the following surgical procedures (≥ 45 minutes in duration) during hospitalization- general surgery, orthopedic surgery, obstetrics and gynecology surgery, neurosurgery, urology surgery, cardiothoracic surgery, obesity surgery or cancer surgery;
- •Hospitalization due to acute spontaneous cerebral hemorrhage:
- •Diagnosed as cerebral hemorrhage (acute/subacute), or subarachnoid hemorrhage, with clinical manifestations such as conscious disturbance, dyskinesia, or sensory dysfunction. Presence of cerebral hemorrhage was confirmed by imaging;
- •Hospitalization due to acute ischemic stroke:
- •Diagnosed as ischemic stroke, ischemic stroke (acute/subacute), cerebral infarction, or cerebral infarction (acute/subacute), acute stage or subacute stage of ischemic stroke, with clinical manifestations such as disturbance of consciousness, motor dysfunction, or sensory dysfunction. Presence of cerebral hemorrhage was confirmed by imaging.
排除标准
- •Received any traditional Chinese medicine (TCM) that contains total saponins of panax notoginseseng (PNS) other than Xueshuantong (lyophilized);
- •Females who are pregnant or breast-feeding;
- •Diagnosed venous thromboembolism occurred before enrollment;
- •Received intravenous thrombolytic therapy for other reasons during hospitalization;
- •Received prophylactic or therapeutic doses of anticoagulants after major surgery;
- •Placed vena cava filters for VTE prophylaxis before surgery;
- •Received therapeutic dose of anticoagulants during the patient's hospital stay (AIS patients);
结局指标
主要结局
Incidence of VTE
时间窗: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Incidence of venous thromboembolism (VTE)
次要结局
- Incidence of PTE(Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS))
- Length of stay(Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS))
- Incidence of proximal DVT(Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS))
- Incidence of symptomatic VTE(Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS))
- Incidence of non-symptomatic VTE(Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS))
- Mortality(Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS))
- Incidence of distal DVT(Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS))
- Wound healing time(Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS))
研究者
Wanmu Xie
chief physician
China-Japan Friendship Hospital
研究点 (14)
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