NCT00290836已完成4 期
An Open, Randomised, Prospective, Single-centre Phase IV Trial to Assess Efficacy and Safety of TachoComb H Versus Standard Surgical Treatment (i.e. Suture) in Patients Undergoing Prostatectomy
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Nycomed
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Efficacy: Is the percentage of patients/treatment group in which efficient intra-operative haemostasis is achieved within 10 minutes after applying test treatment according to randomisation after primary surgical haemostasis.
研究概览
简要总结
The overall objective is to compare efficacy and safety of TachoComb H versus standard surgical treatment for the control of local bleeding in patients undergoing prostatectomy. Specific objectives include the comparison between test treatments for intraoperative haemostatic efficacy as well as for post-operative blood loss to be assessed by haemoglobin and haematocrit concentration of drainage fluid.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •has the subject given informed consent according to local requirements before any trial related activies? A trial related activity is any procedure that would not have been performed during the routine management of the subject.
- •Is the subject 18 years of age or above ?
- •Is the subject planned for a radical prostatectomy for prostate cancer (cT3)?
- •After prostate resection and primary haemostatic treatment
- •is only minor (i.e. oozing) or moderate haemorrhage persisting after primary surgical haemostatic procedures of the major vessels (no pulsating arterial haemorrhage and/or major venous bleeding)?
排除标准
- •At pre-operative screen
- •Is there anamnestic or laboratory evidence of coagulation disorders including haemophilia A or B and von Willebrand disease ?
- •Has the patient a history of allergic reactions after application of human fibrinogen, human thrombin, bovine aprotinin and/or collagen of any origin?
- •Is the patient undergoing an emergency operation?
- •Did the patient participate in a clinical trial less than 30 days prior to inclusion in present trial?
- •Does the patient participate in a clinical trial concomitantly with present trial?
- •After tumour resection and primary haemostatic treatment
- •Has any serious surgical complication occurred?
- •Has any fibrin glue haemostatic (including any type of TachoComb) been used before randomisation?
结局指标
主要结局
Efficacy: Is the percentage of patients/treatment group in which efficient intra-operative haemostasis is achieved within 10 minutes after applying test treatment according to randomisation after primary surgical haemostasis.
次要结局
- Efficacy:
- Haemoglobin concentration of drainage fluid on day 1 after surgery.
- Haemotocrit concentration of drainage fluid on day 1 after surgery.
- Volume of drainage fluid on day 1 after surgery.
- Incidence of post-operative haematoma at removal site at day 2 after surgery (sonography).
- Incidence of tumour positive resection margin proven by histology (discharge).
- Reporting of occurrence of urinary incontinence (discharge, 3 months +/- 10 days (and optional 12 months +/- 30 days) after surgery.
研究者
研究点 (2)
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