NCT06664775招募中3 期
An Open Label, Prospective, Randomized, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of TachoSil® Versus Surgicel™ Original (Oxidized Regenerated Cellulose) as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 14
- 主要终点
- Hemostatic success within 3 minutes
研究概览
简要总结
The purpose of this clinical study is to assess the efficacy and safety of TachoSil compared to the widely known and used for > 60 years local hemostatic product Surgicel Original as an adjunct to control mild to moderate soft tissue bleeding during 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
- None
入排标准
- 年龄范围
- 1 Month 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective open abdominal, retroperitoneal, pelvic, or thoracic surgery. Elective transplant surgery except for liver or heart transplants is included.
- •The participant has a need for secondary hemostatic study intervention at the TBS with mild to moderate bleeding Grade 1 and Grade 2 according to the VIBe Scale.
- •Presence of an appropriate mild to moderate bleeding soft tissue TBS identified intra-operatively by the surgeon.
- •The TBS size < 21 cm2/3.3 in
- •Ability to firmly press study intervention at TBS until 3 minutes after randomization.
排除标准
- •Participants undergoing cardiovascular, hepatic, and laparoscopic and robotic surgeries.
- •Congenital or acquired disorders of coagulation.
- •Diseases requiring constant use of any anticoagulant drugs that cannot be safely washed out prior to randomization.
- •Screening Hemoglobin < 9 mg/dL, platelets < 75 × 103/µL, and/or international normalized ratio (INR) > 1.
- •Acute major bleeding during surgery.
- •Participant with TBS in an actively infected field.
- •Target bleeding site is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency.
- •Target bleeding site with major arterial bleeding requiring suture or mechanical ligation.
- •Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.
- •Participants with Grade '0', '3', and '4' bleeding at TBS according to VIBe Scale.
研究组 & 干预措施
TachoSil
Experimental
干预措施: TachoSil (Biological)
Surgicel Original
Active Comparator
干预措施: Surgicel Original (Biological)
结局指标
主要结局
Hemostatic success within 3 minutes
时间窗: within 3 minutes of study intervention
Proportion of participants achieving hemostatic success at the target bleeding site (TBS) within 3 minutes after application of study intervention
次要结局
- Hemostatic success within 6 minutes(within 6 minutes of study intervention)
- Study intervention failures(within 6 minutes of study intervention)
- hemostatic success from moderate bleeding within 3 minutes(within 3 minutes of study intervention)
研究者
研究点 (14)
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