NCT04083807已完成3 期
A Randomised Controlled Multicenter Single-blinded Phase III Study to Evaluate the Efficacy and Safety of TISSEEL Lyo Compared to Manual Compression as an Adjunct to Haemostasis During Vascular Surgery
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 5
- 主要终点
- Number of participants achieving hemostasis at 4 minutes after treatment
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of TISSEEL Lyo for haemostasis in patients receiving peripheral vascular prosthetic expanded polytetrafluoroethylene (ePTFE) conduits, as compared to a control arm treated with manual compression with surgical gauze pads.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent;
- •Male or female ≥ 18 ages;
- •Patients undergoing primary vascular surgery (i.e., conduit placement with an ePTFE graft), including the following:
- •Arterio-arterial-bypass;
- •Ilio-femoral bypass;
- •Femoro-femoral bypass;
- •Ilio-popliteal bypass;
- •Femoro-popliteal bypass;
- •Femoro-tibial vessel bypass
- •Arteriovenous shunting for dialysis access in the upper or lower extremity;
- •Intraoperative inclusion criterion:
- •Suture line bleeding eligible for study treatment is present after surgical hemostasis.
排除标准
- •Concurrent participation in another clinical study treatment with another investigational drug or device within last 30 days;
- •Other vascular procedures during the same surgical session;
- •Arterio-arterial bypasses with more than two anastomoses;
- •Haemoglobin <9.0 g/dL at screening;
- •Pregnant or lactating women;
- •Congenital or acquired coagulation disorders;
- •Prior kidney transplantation;
- •Heparin-induced thrombocytopenia;
- •Known prior exposure to aprotinin within the last 12 months;
- •Known hypersensitivity to aprotinin, heparin, blood products or other components of the investigational product;
- •Unwilling to receive blood products.
- •Known severe congenital or acquired immunodeficiency;
- •Prior radiation therapy to the operating field;
- •Severe local inflammation at the operating field;
- •Positive results of any of the following the blood tests: HIV, syphilis, hepatitis B, hepatitis C.
- •Emergency surgery.
- •Alcohol or drug abuse.
- •Intraoperative exclusion criteria:
- •Major intraoperative complications that required resuscitation or deviation from the planned surgical procedure;
- •Intraoperative change in planned surgical procedure, which resulted in patient no longer meeting preoperative inclusion criteria or having preoperative exclusion criteria.
研究组 & 干预措施
TISSEEL Lyo
Experimental
Applied once intra-operatively to the study suture line using the DUPLOJECT Fibrin Sealant Preparation and Application System.
干预措施: TISSEEL Lyo (Biological)
Manual compression with surgical gauze pads
Active Comparator
Treated once intraoperatively with manual compression using surgical gauze pads at the study suture line.
干预措施: Manual compression with surgical gauze pads (Procedure)
结局指标
主要结局
Number of participants achieving hemostasis at 4 minutes after treatment
时间窗: Day 0 (4 minutes post-treatment to closure of surgical wound)
Performed on suture line.
次要结局
- Number of participants achieving hemostasis at 6 minutes after treatment(Day 0 (6 minutes post-treatment to closure of surgical wound))
- Number of participants with postoperative re-bleeding after hemostasis(Day 1 (postoperative))
- Number of participants achieving hemostasis at 10 minutes after treatment(Day 0 (10 minutes post-treatment to closure of surgical wound))
- Number of participants with intraoperative re-bleeding after hemostasis(Day 0 (intraoperative))
研究者
研究点 (5)
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