A Prospective, Randomized, Controlled Phase IV Study to Compare Bioseal Versus Standard of Care as an Adjunct to Hemostasis in Elective Brain Tumor Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 8
- 主要终点
- Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS.
研究概览
简要总结
The objective of this study is to observe the clinical utility and performance of Bioseal when used as an adjunct to hemostasis versus Standard of Care (SoC) in elective meningioma 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 meningioma surgery and having a tumor cavity
- •Presence of an appropriate Target Bleeding Site (TBS) as identified intra-operatively by the surgeon requiring an adjunct to achieve hemostasis
- •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 undergoing emergency surgery
- •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 Target Bleeding Site (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 who have a history of traumatic head injury
- •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
Standard of Care (SoC)
Standard of Care (SoC) 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: Standard of Care (SoC) (Other)
Bioseal Fibrin Sealant
A porcine-derived fibrin sealant consisting of thrombin and fibrinogen
干预措施: Bioseal Fibrin Sealant (Biological)
结局指标
主要结局
Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS.
时间窗: Intra-operative, 6 minutes following randomization
The percentage of participants with hemostasis at the Target Bleeding Site (TBS) at 6 minutes following start of treatment application. Hemostasis is defined as no detectable bleeding at the TBS.
次要结局
- Hemostasis at the TBS at 3 Minutes Following Treatment Application(Intra-operative, 3 minutes following randomization)
- Incidence of Potential Bleeding-related Adverse Events(Through 30-day follow-up)
- Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications.(Through 30-day follow-up)