NCT00378872已完成不适用
Prospective Randomised Trial Comparing Intraoperative Topical Quixil and Intravenous Tranexamic Acid, in Reduction of Blood Loss Following Primary Hip & Knee Joint Replacement Surgery.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Blood loss as calculated from change in haematocrit
研究概览
简要总结
We will compare the effectiveness of Quixil and Tranexamic acid in reducing bleeding during hip and knee joint replacements.
详细描述
This is a prospective randomised controlled trial to compare the benefits of Quixil vs. Tranexamic acid in reducing blood loss.
Both medicines are used for the reduction of blood loss in major joint surgery; previous studies have shown each one to be effective and safe, but they have not been directly compared in this setting.
We will compare the blood loss in each of 3 groups: tranexamic acid used, Quixil used, and control group (neither drug used). Blood loss is to be calculated from height, body weight and difference between pre and post-operation haematocrit.
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
- Single
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are to undergo elective hip or knee joint replacement
- •Must be cemented arthroplasty
- •Must be primary arthroplasty
排除标准
- •Uncemented arthroplasty.
- •Revision arthroplasty.
- •Patients on anticoagulant (warfarin, low molecular weight heparin) or other medication known to affect clotting (except aspirin, which is to be given as part of standard DVT prophylaxis in all cases).
- •Other drugs that may affect the activity of the drugs under investigation.
- •Allergy to asprin (all patients to receive 150mg aspirin as standard DVT prophylaxis for 6 weeks).
- •Patients with known coagulopathy (APTT or PT outside normal range pre-operatively).
- •Previous reaction or ethical/religious objection to receiving blood products (Quixil contains a derivative of human blood).
- •Pregnancy or breastfeeding.
- •Patients who have a past medical history of thrombo-embolism at any time.
- •Patients who need intravenous fluid administration for greater than 24 hours following operation.
- •Patients who need allogenic blood transfusion within study period.
- •Jehovah's Witnesses, or any other group of patients with ethical objections to receiving blood products.
结局指标
主要结局
Blood loss as calculated from change in haematocrit
次要结局
未报告次要终点
研究者
研究点 (2)
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