NCT02687399Unknown2 期
A Phase II/III, Randomized, Controlled, Single Blind Study to Evaluate the Haemostatic Efficacy and Safety of Topically Applied TT-173 in Patients Undergoing Knee Arthroplasty
Thrombotargets Europe S.L2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- total blood loss
研究概览
简要总结
The purpose of this study is to determine the haemostatic efficacy of TT-173, reducing the total blood loss associated with the total knee arthroplasty.
详细描述
As the TT-173 has been cleared for use as a topical hemostatic agent, the proposed study will further investigate the safety and efficacy of TT-173 in the knee arthroplasty.
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
- Single (Participant)
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 who signed the informed consent.
- •Patients affected of degenerative osteoarthritis of the knee that have to undergo a primary total knee replacement.
- •Patients of both sexes older than 18 years.
- •Female patients in childbearing age* that are not permanently sterile, should present a negative pregnancy test and should agree to use a medically accepted anti contraceptive method during its participation in the study. This includes oral, intravaginal, transdermal, injectable or implantable hormonal contraceptives, sexual abstinence, bilateral tubal occlusion, intrauterine hormone-releasing system or dispositive and vasectomy of the partner.
- •* Includes the period between menarche and until becoming post-menopausal. A woman is considered post-menopausal when she has gone without a period for 12 consecutive months.
- •Patients must have a haemoglobin concentration ≥ to 12.5 g/dL at the selection visit.
排除标准
- •Patients affected of any kind of congenital or acquired coagulopathies or with personal history of abnormal haemorrhagic episodes.
- •Patients subjected to knee replacement due to rheumatoid or seronegative arthritis, infection or other autoimmune inflammatory causes of join degeneration.
- •Patients subjected to revision procedures of the knee, hemiarthroplasty or that will receive non-cemented knee prosthesis.
- •Subjects affected of a serious medical condition that would compromise their clinical outcome such as hepatic, respiratory, cardiac or renal insufficiency, acute infectious disease and active cancer.
- •Subjects with known history of haematological alterations which are causative of thrombophilia.
- •Subjects with personal history of deep vein thrombosis, pulmonary thromboembolism, retinal vascular occlusion or multiple abortions.
- •Subjects with known hypersensitivity or allergy to any component of the drug.
- •Subjects that are currently under treatment with anticoagulant, antiplatelet or antifibrinolytic drugs. These subjects may be eligible if the treatment is stopped preoperatively according with the conditions indicated in section 9.
- •Subjects who have received treatment (erythropoietin, iron, folate) to improve preoperative anaemia.
- •Subjects who are not free to give informed consent or who are mentally incapacitated to the discretion of investigators.
- •Subjects who participate or have participated in the past three months in another clinical trial with drug treatment.
- •Subjects that are the investigators, collaborators, nurses, centre employees or any other person directly related to the development of the protocol.
- •Subjects who are pregnant or lactating.
研究组 & 干预措施
placebo
Placebo Comparator
It will be sprayed over the surgical lesion surfaces on the exposed tissues of the knee
干预措施: placebo (Other)
TT-173
Experimental
It will be sprayed using this syringe and a nozzle tip couplet to it one time over the surgical lesion surfaces on the exposed tissues of the knee
干预措施: TT-173 (Biological)
结局指标
主要结局
total blood loss
时间窗: 2 day
次要结局
- Transfusion rate(35 days)
- Maximum decrease in venous haemoglobin concentration(2 day)
- Number of units of blood concentrates transfused(35 days)
- Immunogenicity (detectable increase of reactive antibodies against the product )(35 days)
- Blood collected in the drainage(1 day)
- Range of knee motion (Knee flexion and extension)(35 days)
- Systemic absorption (detectable increase of TF blood concentration at any time of the pharmacokinetics sampling)(15 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Determine the Haemostatic Efficacy of TT-173, Reducing the Bleeding Time in the Donor Site of Skin GraftingBurnsTraumatic LesionsNCT02012569Thrombotargets Europe S.L78
已完成
2 期
Safety and Efficacy of ART-123 in Subjects With Sepsis and Disseminated Intravascular CoagulationSepsisDisseminated Intravascular CoagulationNCT00487656Artisan Pharma, Inc.750
已完成
1 期
Safety, Tolerability and Efficacy Study of TT-173 in Healthy Volunteers After Tooth ExtractionTooth ExtractionNCT01595360Thrombotargets Europe S.L24
已完成
3 期
TachoSil Paediatric Liver Trial (TC-019-IN)Liver DiseasesNCT00365248Nycomed16
招募中
不适用
Interventional study on the reduction of thrombus using rivaroxaban for deep vein thrombosis and pulmonary thromboembolismvenous thromboembolismJPRN-UMIN000032996Toho University40