NCT00241163已完成3 期
An Open, Randomised, Prospective, Multicentre, Parallel-group Trial to Compare Efficacy and Safety of TachoComb S Versus Standard Surgical Treatment in Patients Undergoing Surgical Resection of Superficial Renal Tumour.
Takeda1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2005年10月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Primary efficacy endpoint is overall time to intraoperative haemostasis from start of test treatment until haemostasis is obtained following 1 or 2 rounds of randomised treatment,and other haemostatic treatment, if necessary.
研究概览
简要总结
The overall objective is to compare efficacy and safety of TachoComb S and standard surgical treatment for the control of local bleeding in patients undergoing surgical resection of renal tumours. Specific objectives include the comparison between test treatments of intra-operative haemostatic efficacy as well as post-operative blood loss, haematoma formation, and surgeon's rating of usefulness of test treatment.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of or above 18 years of age scheduled for resection of superficial tumour on the kidney and scheduled for open surgery. After the tumour resection the wound should be suitable for the treatments in the study, and the integrity of the urinary tract should be maintained.
排除标准
- •Patients undergoing an emergency operation, or with more than one tumour will be excluded. Patients with a clinically abnormal value of prothrombin time or activated partial thromboplastin time, anamnetic evidence of coagulation disorders and a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen will be excluded. In case the tumour was resected by use of a laser scalpel, infrared coagulator or argon beamer and if any fibrin glue haemostatic was used before randomisation the patient will be excluded from the trial. Furthermore, patients will be excluded if extensive resection/extirpation of the kidney become necessary or in case of serious surgical complication occurring during the operation.
结局指标
主要结局
Primary efficacy endpoint is overall time to intraoperative haemostasis from start of test treatment until haemostasis is obtained following 1 or 2 rounds of randomised treatment,and other haemostatic treatment, if necessary.
次要结局
- Secondary efficacy endpoints are: 1) proportion of patients with haemostasis 10 minutes after start of test treatment; 2) haematoma formation on day 2 after surgery (sonography).
- Adverse events will be recorded from screening until follow-up.
研究者
研究点 (1)
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