A Multicenter, Randomized, Single-blind, Active-Controlled, Parallel Group, Phase III Clinical Study Report to Evaluate the Efficacy and Safety of 'Hemofence' for Hemostasis in Patients With Exudative Hemorrhage Uncontrolled or Ineffectively Controlled by Conventional Procedures in Spinal/Orthopedic Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 3
- 主要终点
- Percentage of Participants With Successful Hemostasis at the First Bleeding Site Within 10 Minutes
研究概览
简要总结
This Phase 3 study was conducted to evaluated the efficacy and safety of Hemofence compared with Floseal Hemostatic Matrix in patients undergoing spinal or orthopedic surgery who required hemostasis for exudative bleeding that could not be adequately controlled by conventional procedures. Eligible participants were randomly assigned in a 1:1 ratio to receive either Hemofence or Floseal Hemostatic Matrix. The primary objective was to demonstrate the non-inferiority of Hemofence to Floseal Hemostatic Matrix based on the proportion of participants who achieved successful hemostasis within 10 minutes after the initial application of the assigned treatment at the first bleeding site. Safety was assessed through adverse events, clinical laboratory tests, vital signs, electrocardiograms, and physical examinations.
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 (Participant)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •[At Screening (Preoperative)]
- •Individuals aged 19 years or older and under 80 years, scheduled for non-emergency spinal/orthopedic surgery
- •Subjects who have voluntarily agreed to participate after receiving a thorough explanation of the clinical trial and fully understanding its details, and who have provided written informed consent to comply with the instructions of the trial
- •[Surgery Day (Preoperative)]
- •Subjects with an INR result of ≤ 1.5 in tests performed before surgery
- •Subjects with normal platelet function or results below the lower limit of normal in platelet adhesion COL/EPI tests, but deemed clinically insignificant by the investigator
- •[Surgery Day (Intraoperative)]
- •Subjects requiring hemostasis for exudative hemorrhage that cannot be effectively controlled or is uncontrollable by conventional procedures
- •Subjects without severe arterial bleeding or similar conditions
排除标准
- •Subjects who received platelet or plasma transfusions affecting hemostasis within 3 weeks prior to the surgery day
- •Subjects with active infections at the surgical site
- •Subjects with a history of bleeding, platelet, or bone marrow disorders
- •Subjects with coagulation disorders
- •Subjects with immune system diseases
- •Subjects currently receiving or scheduled to receive procoagulants, antifibrinolytics, or aprotinin during surgery
- •Subjects scheduled to use antibiotic solutions or powders at the investigational product application site during surgery (excluding irrigation agents applied after the hemostasis evaluation at the investigational product application site and during surgical site closure)
- •Subjects who received medication affecting bleeding and hemostasis (e.g., anticoagulants, antiplatelet agents, thrombolytics such as aspirin, clopidogrel, NSAIDs, warfarin) within 7 days prior to the surgery date (Visit 2)
- •Subjects who expected to require anticoagulatnt therapy within 48 hours postoperatively
- •Subjects with hypersensitivity to bovine-derived materials or any component of the investigational product
- •Subjects with renal implairment (serum creatinine levels exceeding 1.5 times the institution's upper limit of normal)
- •Subjects with hepatic impairment (ALT or AST levels exceeding 3.0 times the institution's upper limit of normal)
- •Subjects with disease such as disseminated intravascular coagulation (DIC) or other conditions of concern regarding decreased fibrinolytic system activity
- •Subject with a history of alcohol or drug abuse
- •Female subjects with childbearing potential or male subjects with partners of childbearing potential who are unwilling to use medically accepted contraception methods during the clinical trial period (e.g., hormonal contraception, intrauterine device [IUD] or intrauterine system [IUS], tubal ligation, double barrier methods such as male or female condoms, cervical caps, diaphragms, or sponges combined with spermicide, or a single barrier method with spermicide)
- •Pregnant or breastfeeding women
- •Subjects who participated in another clinical trial within 4 weeks prior to this trial
- •Any other condition that the investigator deems unsuitable for participation
研究组 & 干预措施
Experimental Group
Participants assigned to this arm received Hemofence for exudative bleeding that could not adequately controlled by conventional procedures during spinal or orthopedic surgery.
干预措施: Hemofence (Drug)
Active Control Group
Participants assigned to this arm received Floseal Hemostatic Matrix for exudative bleeding that could not adequately controlled by conventional procedures during spinal or orthopedic surgery.
干预措施: Floseal hemostatic matrix (Drug)
结局指标
主要结局
Percentage of Participants With Successful Hemostasis at the First Bleeding Site Within 10 Minutes
时间窗: Within 10 minutes after the initial application of the assigned treatment
次要结局
- Percentage of Participants With Successful Hemostasis at the Second Bleeding Site(Within 10 minutes after the initial or subsequent application of the assigned treatment)
- Time to Hemostasis at the First Bleeding Site(From application of the assigned treatment until hemostasis, up to 10 minutes)
- Time to Hemostasis at the Second Bleeding Site(From application of the assigned treatment until hemostasis, up to 10 minutes)