EUCTR2007-007254-62-DE进行中（未招募）不适用
on-randomised, open, multi-center trial evaluating feasibility and safety of TachoSil application on a colorectal anastomosis. - Evaluation of TachoSil application on a colorectal anastomosis.
ycomed Danmark ApS0 个研究点目标入组 30 人开始时间: 2008年3月12日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •1. Has the patient given informed consent according to local requirements before any trialrelated activities? A trial-related activity is any procedure that would not have been performed during the routine management of the subject
- •2. Is the subject 18 years of age or above?
- •3. Is the subject scheduled for elective resection of the rectum?
- •4. Is a colorectal anastomosis below the peritoneal reflexion planned?
- •For females of childbearing potential:
- •5. Does the patient use an acceptable contraceptive method (contraceptive pills, injection of prolonged gestagen, subdermal implantation, hormonal vaginal devices, transdermal patches or intrauterine device (IUD))?
- •6. Is the blood or urine pregnancy test negative?
- •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
- •1. Is the subject scheduled for emergency resection of the rectum?
- •2. Does the subject suffer from inflammatory bowel diseases?
- •3. Does the subject have a history of hypersensitivity reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
- •4. Has the subject participated in any other trial with an investigational medical product (IMP) or device within 30 days before inclusion in this trial?
- •5. Does the subject participate or plan to participate in another clinical trial during the trial period?
- •For females of childbearing potential:
- •6. Is the subject pregnant or breast feeding?
- •Exclusion - peroperative
- •7. Was an anastomosis performed differently from what was defined in the inclusion
- •8. Did the subject receive any fibrin sealant/glue, excluding TachoSil®, during surgery?
研究者
相似试验
进行中（未招募）
1 期
on-randomised, open, multi-center trial evaluating feasibility and safety of TachoSil application on a colorectal anastomosis. - Evaluation of TachoSil application on a colorectal anastomosis.The scope of this trial is to evaluate if it is possible to apply TachoSil around colorectal anastomosis and evaluate its feasibility in future clinical trials. Therefore the only focus is on the validation of the TachoSil application method.EUCTR2007-007254-62-GBycomed Danmark ApS30
进行中（未招募）
不适用
on-randomised, open, multi-center trial evaluating feasibility and safety of TachoSil application on a colorectal anastomosis. - Evaluation of TachoSil application on a colorectal anastomosis.EUCTR2007-007254-62-NLycomed Danmark ApS30
已完成
3 期
on-randomised,open, multi-center trial evaluating feasibility and safety of Tachosil application on a colorectal anastomosisNL-OMON31912ycomed7
进行中（未招募）
1 期
Trial to be conducted in more sites, with drug known to both patient and Investigator, in which patients will be assigned randomly to receive the drug or not in order to assess the efficacy and tolerability of the drug (porcine surfactant, Curosurf®) in hospitalized patients with SARS-COV-19 (COVID-19 INFECTION) acute respiratory distress syndromepatients with SARS-COV-19 acute respiratory distress syndrome (ARDS)EUCTR2020-002632-75-GBCHIESI FARMACEUTICI S.p.A85
进行中（未招募）
不适用
Multicenter, randomized, open-label trial to evaluate the safety, tolerability and efficacy of two regimens of Everolimus plus Neoral, given according different blood target levels, in de novo renal transplant recipients Everest the upper target EVErolimus RandomizEd STudyPrevention of rejection in adult renal transplant patients in combination with Neoral and corticosteroidsMedDRA version: 6.1Level: PTClassification code 10023439EUCTR2005-000864-16-ITOVARTIS FARMA200