Effect of Tranexamic Acid in Proximal Humeral Fracture Surgery. A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Perioperative blood loss
研究概览
简要总结
The purpose of this study is to determine the effect of tranexamic acid (on blood loss and transfusion requirements in patients with proximal humeral fractures requiring open surgical approaches.
This a blinded, controlled, therapeutic trial in which the patients will be randomized to receive TXA or no drug intervention. The primary outcome is the estimated total blood loss.
This study presents only minimal risks for the included patients.
详细描述
Studies have shown that hip fractures have a significant perioperative blood loss. Postoperative anaemia is associated with a higher morbidity and mortality.
Tranexamic acid is a safe and effective antifibrinolytic widely used to reduce blood loss in other forms of orthopaedic surgery and in traumatized patients. However, evidence on the effectiveness of TXA in shoulder fractures is more limited. Proximal humeral fractures represent a common orthopedic injury in elderly patients The goal of this study is to assess if the use of topic tranexamic acid in patients with proximal humeral fractures will result in a reduction in blood losses and blood transfusion rates.
The hypothesis is that by providing topic TXA at the end of surgery will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for postoperative transfusion.
This a blinded, controlled, therapeutic trial in which the patients will be randomized to receive TXA or no drug intervention. The primary outcome is the estimated total blood loss. Secondary outcomes, need for blood transfusion, length of stay, and rate of thromboembolic events.
Candidates for the study will be consecutive patients with a diagnosis of proximal humeral fracture. All patients meeting inclusion criteria will be recruited for enrollment into the study. Informed consent will be obtained from the patient prior to randomization.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients will be allocated into two groups based on randomized 20-block method by an independent assistant using computer generated randomization
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
- •Acute proximal humeral fracture
- •Age over 18 years
排除标准
- •Concomitant fracture
- •Refusal to receive blood products
- •Allergy for tranexamic acid
- •Severe hepatic dysfunction (AST/ALT >60)
- •Renal function impairment (serum creatinine > 2 mg/dL or creatinine clearance <30 mL/min),) or kidney transplant
- •Active acute thromboembolic event in the past 12 months (Deep Vein Thrombosis, Pulmonary)
- •Active coronary artery disease or cerebrovascular accident (event in the past 12 months).
- •Coronary stents
- •History of hypercoagulability
- •Coagulopathy (INR > 1.4)
研究组 & 干预措施
TXA group
Tranexamic acid, a topic dose of 2 g diluted in 50 mL saline solution infused in shoulder joint
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Perioperative blood loss
时间窗: Hospital stay, from admission to third postoperative day.
Measurement of loss (in mL), calculated with mathematical formulas proposed by Nadler and Good
次要结局
- Thrombotic event rate(90 postoperative days.)
- Blood transfusion rate(Hospital stay, from admission to third postoperative day)
- Infection rate(90 postoperative days)
研究者
Alejandro Lizaur-Utrilla, PhD, MD
Head of Orthopaedic Surgery Department
Elda University Hospital