EUCTR2006-002332-17-GB进行中（未招募）1 期
Prospective, randomised trial comparing the use of Tisseel versus no fibrin sealant in preventing postoperative fluid complications following liver resection - Tisseel 1
The Leeds Teaching Hospitals NHS Trust0 个研究点目标入组 242 人开始时间: 2007年3月9日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 242
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female patients of any race, between 18 and 90 years of age.
- •Patients due to undergo liver resection.
- •Female patients of child bearing potential must have a negative urine pregnancy test prior to random assignment.
- •Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study. Patient unable to write and/or read but who fully understands the oral information given by the investigator (or nominated representative) and has given oral informed consent witnessed by an independent person.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient has known hypersensitivity to aprotinin
- •Patient has had a previous liver resection where Tisseel was used (risk of hypersensitivity)
- •Patient has known abnormal liver parenchyma (significant fibrosis or cirrhosis)
- •Patient has pre-operative coagulation disorders (PT > 20 seconds)
- •Patient has pre-operative ascites
- •Patient has platelet count of <75 000
- •Patient is participating or has participated in another clinical trial and/or is taking or has been taking an investigational drug in the past 3 months
- •Patient is pregnant or breast feeding
- •Abnormal liver parenchyma determined intra-operatively (significant fibrosis or cirrhosis)
- •Failure to achieve haemostasis without the need of sealants
- •Concomitant bile duct reconstruction
- •Lymphadenectomy in excess of regional
研究者
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