EUCTR2020-003321-32-DK进行中（未招募）1 期
Evaluation of intra articular Tranexamic acid for reduction of total blood loss in total hip arthroplasty
Hvidovre Hospital, Dep. of Orthopaedic Surgery0 个研究点目标入组 100 人开始时间: 2020年7月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •= 18 years
- •Undergoing surgery for unilateral total hip arthroplasty
- •Able to give ones consent either verbally or written.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •- Operation performed in general anaesthesia
- •- Allergi to TXA
- •- In treatment with the following anticoagulatia: ADP receptorinhibitors, vitamin-K antagonist(within 5-7 days before the operation). Factor Xa inhibitors, thrombine-inhibitors
- •- Use of oral anticonceptiva
- •- Kown with thrombophilia
- •- Reduced kidney function (GFR <60 ml/hour)
- •- Participated in a clinical trial within the last 30 days
- •- Alcoholism and morphinism
- •- Females: menstruation within the last 12 months
- •- Patients who are not able to speak and understand Danish
- •- Patients who refuse to receive blood products
- •- Present acute thromboembolic event (DVT, AMI, cerebral infarction, pulmonary embolism)
- •- Disseminated intravascular coagulation (DIC) or active thromboembolic disease
- •- Active cancer disease
- •- Had one of the following type of trauma or surgeries in the affected hip: Hip fractures, periacetabulær osteotomy, femurosteotomy, trochanterostetoyi.
- •- Rheumatic arthritis.
研究者
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Does tranexamic acid, a medicine used in treating and preventing bleeding problems, reduce the blood loss when it is injected directly into the knee joint after a total knee prosthesisThe benefit of additional Tranexamic Acid (TXA) injected intra-articular at the end of surgery for patients undergoing a unilateral total knee arthroplasty in addition to conventional IV TXA to reduce the bleeding.MedDRA version: 14.1Level: LLTClassification code 10003398Term: Arthroplasty of kneeSystem Organ Class: 100000004865EUCTR2013-003169-33-DKAnders Troelsen
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