Anti-fibrinolytic and Anti-inflammatory Effects of Local Infiltration of Tranexamic Acid in the Post-operation of Displaced Intra-articular Calcaneal Fractures: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Incision drain output (mL)
研究概览
简要总结
Background. Consensus is lacking regarding the use of tranexamic acid (TXA) in calcaneal fracture surgery. This study aims to investigate the hypothesis that local infiltration of TXA in the post-operation would maintain hemoglobin (Hb) level, reduce incision drainage volume and risk of infection in patients with displaced intra-articular calcaneal fractures. Methods. A total of 120 patients with displaced intra-articular calcaneal fractures who received extensible lateral L-shaped approach were included in this trial and equally randomized to receive one single dose of 1g TXA or 1g normal saline after closing incision. The demographic data and fracture characteristics, intra-operative indicators, laboratory tests and Visual Analogue Scale (VAS) scores, incision drainage volume, and incision-related complications were collected and compared between the two groups.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients with age of eighteen years or older;
- •diagnosis of closed and unilateral displaced intra-articular calcaneal fracture;
- •agreement to receive one of the two treatment strategies;
- •agreement to participate in regular follow-up after surgery
排除标准
- •open calcaneal fractures;
- •polytrauma of the ipsilateral lower limb;
- •systemic inflammatory or infectious diseases;
- •previous history of calcaneal fracture or bone tumor;
- •allergies to drugs used, or refused to accept the specified treatment strategy.
研究组 & 干预措施
TXA group
Postoperative 1g TXA was infiltrated locally around the incision immediately for patients in TXA group.
干预措施: Tranexamic acid (Drug)
Normal saline group
1 g 0.9% saline was infiltrated locally around the incision immediately after surgery for patients in normal saline group.
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Incision drain output (mL)
时间窗: 2 days
Incision drain output of post-operative day 1 and 2
Outcomes of laboratory test
时间窗: 4 days
Hemoglobin (g/L)
次要结局
- Incidence of surgical related complications(30 days)