EUCTR2011-006059-13-IT进行中（未招募）不适用
The use of Tachosil as sealant in the prevention of lymphorrea after groin lymphadenectomy for vulvar cancer: a clinical controlled prospective trial - Tacho01
A.O. UNIVERSITARIA INTEGRATA DI VERONA0 个研究点开始时间: 2012年6月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- Female
入选标准
- •- Patients with histological diagnosis of vulvar cancer; - Stromal invasion > 1mm at the biopsy; - Performance status 0,1,2 o 3; - Platelets > 100000/mmc; - Creatinine <2 mg/dl; - Bilirubin <1.5 x normal value; - AST e ALT < 3 x normal value.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •- Previous Radio-Chemotherapy; - Pre-existing primary and secondary lower extremity lymphedema; - Superficial phlebitis or ulcer or lower extremity chronic infection; - Sealant excipients hypersensitivity.
研究者
相似试验
进行中（未招募）
1 期
se of TachoSil® for the prevention of postoperative complications afterremoval of lymphnodes in groin in vulva cancer patientsVulva cancerMedDRA version: 19.1Level: HLTClassification code 10047750Term: Vulval neoplasms malignantSystem Organ Class: 100000004864EUCTR2016-001191-30-DKDepartment of Obstetrics & Gynecology, Copenhagen University Hospital, Rigshospitalet70
进行中（未招募）
不适用
The purpose of this trial is to scientifically assess the performance andsafety of TachoSil when used as a seal to prevent the leaking of brainfluid in patients who have undergone skull based surgery. TachoSil willbe compared to the current practice already used within the hospitalSkull base surgery for the prevention of postoperative cerebrospinal fluid (CSF) leaksMedDRA version: 14.1Level: PTClassification code 10067908Term: NeurosurgerySystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2009-013056-71-SETakeda Pharma A/S726
尚未招募
3 期
TachoSil® versus current practice in dura sealing techniques for the prevention of postoperative cerebrospinal fluid (CSF) leaks in patients undergoing skull base surgery: An open label, randomised, controlled, multicentre, parallel group efficacy and safety trial.Leakage of brain fluids.10040795NL-OMON32695ycomed28
进行中（未招募）
不适用
The purpose of this trial is to scientifically assess the performance and safety of TachoSil when used as a seal to prevent the leaking of brain fluid in patients who have undergone skull based surgery. TachoSil will be compared to the current practice already used within the hospitalSkull base surgery for the prevention of postoperative cerebrospinal fluid (CSF) leaksMedDRA version: 14.1Level: PTClassification code 10067908Term: NeurosurgerySystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2009-013056-71-NLycomed Danmark ApS726
进行中（未招募）
1 期
TachoSil versus current practice in dura sealing techniques for the prevention of postoperative cerebrospinal fluid (CSF) leaks in patients undergoing skull base surgery: An open label, randomised, controlled, multicentre, parallel group efficacy and safety trial. - TASALL -TachoSil Against Liquor LeakSkull base surgery for the prevention of postoperative cerebrospinal fluid (CSF) leaksMedDRA version: 12.0Level: PTClassification code 10067908Term: NeurosurgeryEUCTR2009-013056-71-FRycomed Danmark ApS726