Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)

Nycomed1 个研究点分布在 1 个国家目标入组 500 人开始时间: 2007年6月最近更新: 2012年5月7日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Nycomed
入组人数: 500
试验地点: 1

研究概览研究设计入排标准研究组 & 干预措施研究者研究点记录与标识符相似试验

研究概览

简要总结

Effectiveness and reliability of TachoSil in cholecystectomy (elective and acute)
Evaluation of TachoSil in laparoscopic cholecystectomy
Risk profile of patient under anticoagulant therapy undergoing acute cholecystectomy
Pharmaco-economic evaluation
Recording of AE's/SAE's Considering the total number of cholecystectomies in Germany (170.000 cases/y), out of them about 75% laparoscopic and 10.000 conversions totally it seems urgent to record data about usage of TachoSil in such procedures. For the time being TachoSil is applied in about 2% of the gall bladder procedures.

Aim is to evaluate a possible patient and procedure profile where TachoSil is most beneficial.

研究设计

研究类型: Observational
观察模型: Case Control
时间视角: Prospective

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 undergoing elective or acute cholecystectomy
•The only restrictions of use will be those resulting from the contraindications (see section 4.3 of the Summary of Product Characteristics)

排除标准

未提供

研究组 & 干预措施

A

干预措施: Fibrinogen (human) + thrombin (human) (TachoSil) (Drug)

研究者

发起方

Nycomed

申办方类型

Industry

研究点 (1)

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