NCT01260818Unknown不适用
Prospective Randomized Trial Comparing Topical Tranexamic Acid Plus Standard Of Care Versus Standard Of Care For The Reduction Of Blood Loss Following Primary Total Hip Arthroplasty Surgery
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Blood loss as calculated from change in haematocrit
研究概览
简要总结
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted intravenously in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of topical use of tranexamic acid in reduction of blood loss and transfusions for total hip 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who are to undergo elective total hip arthroplasty.
- •Must be primary arthroplasty.
- •Must be single-side arthroplasty.
- •Must be older than 18 years.
排除标准
- •Cemented arthroplasty.
- •Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia .
- •Patients with known coagulopathy (APTT or PT outside normal range pre-operatively).
- •Patients who have a past medical history of thrombi-embolism at any time.
- •Patients with anemia (hemoglobin levels less than 8 mg/dl or hematocrit <24%).
- •Patients with documented DVT or PE at screening or in past three months.
- •Patients having known hypersensitivity to tranexamic acid or any other. constituent of the product.
- •Patients with any associated major illness (e.g., severe cardiac [New York Heart Association Class III or IV] or respiratory disease).
- •Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week.
- •Jehovah's Witnesses, or any other group of patients with ethical objections to receiving blood products.
研究组 & 干预措施
Tranexamic Acid
Experimental
干预措施: Tranexamic Acid (Drug)
control group
Placebo Comparator
干预措施: normal saline (Drug)
结局指标
主要结局
Blood loss as calculated from change in haematocrit
时间窗: 7 days
次要结局
- Intra-operative blood loss(1 day)
- Postoperative blood loss(postoperative 4 hours, 1 day, 2 days, 7days respectively)
- Hemoglobin levels(postoperative 4 hours, 1 day, 2 days, 7days respectively)
- drainage volume(postoperative 1 day, 2 days)
- Proportion of patients receiving transfusions(7 days)
- Incidence of deep vein thrombosis postoperatively(7 days)
研究者
研究点 (1)
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