A Prospective, Randomized, Controlled Phase IV Study to Compare Bioseal Versus Manual Compression as an Adjunct to Hemostasis in the Patients Undergoing Elective Vascular Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 11
- 主要终点
- Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application.
研究概览
简要总结
To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective vascular surgery.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between 18 and 75 years of age;
- •Undergoing elective vascular surgical procedures and with the presence of an appropriate Target Bleeding Site (TBS) requiring an adjunct to achieve hemostasis as identified intra-operatively by the surgeon ;
- •Able and willing to comply with procedures required by protocol;
- •Signed and dated written informed consent prior to any study related procedures.
排除标准
- •Subjects with any intra-operative findings that may preclude conducting of the study procedures;
- •Intended use of Fibrin Sealants (including autologous Fibrin Sealants) other than Bioseal on the TBS;
- •Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
- •Subjects with known allergies to or previously used porcine derived products;
- •Female subjects who are known breastfeeding or pregnant or intend to become pregnant during the clinical study period.
- •The subject, in the opinion of the investigator, would not be suitable for participation in the study.
- •Subjects who participated in another trial within 30 days prior to the planned start of treatment.
研究组 & 干预措施
Bioseal Fibrin Sealant
A porcine-derived fibrin sealant consisting of thrombin and fibrinogen
干预措施: Bioseal Fibrin Sealant (Biological)
Manual compression
Manual compresssion (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
干预措施: Manual Compression (Other)
结局指标
主要结局
Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application.
时间窗: Intra-operative, 10 minutes following randomization
Percentage of participants with Hemostasis at the TBS at 10 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.
次要结局
- Number of Participants Requiring Alternative Treatment Due to Treatment Failure*(Intra-operative, 10 minutes following randomization)
- Percentage of Participants With Potential Bleeding-related Adverse Events(30-days follow-up)
- Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application(Intra-operative, 3 and 6 minutes following randomization)