A Prospective Randomized Trial of Hemopatch Versus No Hemopatch For the Intraoperative Hemostasis During Deceased Donor Renal Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Blood Loss
研究概览
简要总结
Kidney transplantation remains one of the most common organ transplanted today but the surgical technique has changed very little from the original pelvic operation. The deceased donor renal transplant poses a particular challenge to the surgeon due to lack of detailed pre operative vascular assessment. The hemopatch is a promising new sealing synthetic hemostatIc agent with a novel dual mechanism of action that is more convenient to apply rather then using other hemostatic agents, which require warming and/or mixing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Patients at least 18 years of age and capable of giving informed consent
- •Patients scheduled for deceased donor renal transplant surgery
排除标准
- •Patient undergoing live related transplant surgery.
- •Patient having uncorrectable bleeding diathesis.
- •Any patient in the no hemopatch group requiring additional haemostatic agents for achieving hemostasis like fibrillar or surgical.
研究组 & 干预措施
Standard technique
Standard hemostatic agents (floseal, tisseal).
干预措施: No Hemopatch (Device)
Hemopatch
The hemopatch is a promising new sealing synthetic hemostatic agent with a noval dual mechanism of action. The hemopatch is a polyethylene glycol coated (PEG coated) collagen patch. The PEG coating helps in rapid adhesion to the tissue surface while the collagen layer causes platelet activation and adhesion.
干预措施: Hemopatch (Device)
结局指标
主要结局
Blood Loss
时间窗: Baseline (Intraoperatively)
Blood loss will be measured in ml (cc).
次要结局
- Amount of Perigraft Collection(up to 48 hours postoperative)
- Hemostasis achievement(Baseline (Intraoperatively))
- Drop in Hemoglobin(up to 48 hours postoperatively)
研究者
Anil Kapoor
MD, FRCSC
St. Joseph's Healthcare Hamilton