TOPICAL AND INTRAVENOUS ADMINISTRATION OF TRANEXAMIC ACID ARE EQUALLY EFFECTIVE IN DIRECT ANTERIOR TOTAL HIP ARTHROPLASTY - A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative Bloodloss
研究概览
简要总结
Through a randomized controlled trial, we will compare the intravenous administration of tranexamic acid with the intra-articular application after a total hip arthroplasty through direct anterior approach.
- RCT, prospective study
- Academic-monocentric study
- Clinical outcome measurements The postoperative blood loss will be the primary outcome. Secondary outcomes are
- The rate of perioperative and postoperative blood transfusion
- The number of blood units transfused
- The length of hospital stay
- Perioperative given intravenous isotonic fluid
The Null-hypothesis is that there is no significant difference in postoperative blood loss between intra-articular and intravenous administration of TXA.
详细描述
Study protocol:
Topical application of tranexamic acid compared to the intravenous administration in total hip arthroplasty with the direct anterior approach A prospective, randomized, clinical trial
Researchers: B. Jacobs and Dr. S. Ghijselings Supervisors: Dr. R. Driesen, Dr. M. Beran, Dr. R. Heylen Coördinerend supervisor: Prof dr. K. Corten
Background
The prevalence of total hip arthroplasty (THA) is increasing and the accompanied blood loss cannot be overlooked. In 2007, 17,347 patients underwent THA in Belgium and that number grows every year by an average of 2.9%. The average amount of blood loss associated with THA was ranging from 1000 to 2000mL. Therefore the substantial perioperative blood loss frequently necessitates blood transfusion. Although complications have decreased, morbidity and high costs due to blood transfusion still exist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
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
- •All adults (patients over the age of eighteen years) who were scheduled for a primary unilateral total hip arthroplasty due to osteoarthritis at Ziekenhuis Oost-Limburg, Genk, Belgium are eligible for inclusion in the study.
排除标准
- •History of coagulopathy
- •Allergy to tranexamic acid
- •preoperative anemia
- •fibrinolytic disorders
- •history of arterial or venous thromboembolic disease
- •disturbances of color vision
- •pregnancy
- •breastfeeding
- •major comorbidities
- •participation in another clinical trial
研究组 & 干预措施
Intravenous tranexamic acid
Will receive 1.5g intravenous tranexamic acid preoperatively
干预措施: 1.5g intravenous Exacyl (Drug)
Intra-articular tranexamic acid
Will receive 3g intra-articular tranexamic acid after wound closing
干预措施: 3.0g intra-articular Exacyl (Drug)
结局指标
主要结局
Postoperative Bloodloss
时间窗: Day 1 after surgery
Measured with a simple blood sample on day one after surgery
次要结局
- Rate of perioperative and postoperative blood transfusion(Patients will be followed for the duration of hospital stay, an expected average of 5 days)
- Number of blood units transfused(Patients will be followed for the duration of hospital stay, an expected average of 5 days)
- Perioperatively given intravenous isotonic fluid(Patients will be followed for the duration of hospital stay, an expected average of 5 days)
- Length of hospital stay(Measured when patient goes home, minimum 5 days after surgery)
- Severity of pain at rest as determined with use of a visual analog scale(Patients will be followed for the duration of hospital stay, an expected average of 5 days)
研究者
Jacobs Brecht
Medical student
Ziekenhuis Oost-Limburg