"Randomized, Double-blind Clinical Trial to Assess the Efficacy of Tranexamic Acid in Reducing Blood Loss in Patients With Hip Fracture"
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 644
- 试验地点
- 1
- 主要终点
- Blood transfusion
研究概览
简要总结
Hip fracture in elderly patients is a pathology with a high economic and health impact on the patient himself and on the National Health System, especially considering the significant aging of the population of the Basque Country. Despite advances, hip fracture remains in the clinical groups with the highest in-hospital mortality. Hip fracture is associated with numerous adverse events and high mortality.
Numerous antifibrinolytics, such as tranexamic acid (TXA), have been used to limit bleeding in orthopedic surgery and thus prevent the need for blood transfusion. Numerous studies have shown that the use of tranexamic acid does not increase the risk of thrombosis.
It is proposed to carry out clinical research with drugs without commercial interest. A randomized, double-blind clinical trial to assess the efficacy of tranexamic acid in reducing blood loss in elderly patients with hip fracture.
详细描述
Prevention and treatment of bleeding due to general or local fibrinolysis
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over or equal to 65 years of age, of both sexes, who are going to be operated on for a hip fracture
- •Accept participation in the study (informed consent that will be signed by the patient or family member/legal representative depending on the patient's degree of autonomy).
排除标准
- •Under treatment with another experimental drug (who is not participating in another clinical trial with an experimental drug).
- •The refusal of the patient or their relatives/legal representative to participate in the study.
- •Known allergy to TXA ( Hipersensivity to TXA o to any of the excipients).
- •Patients with a history of seizures.
- •Patients with severe renal and hepatic insufficiency.
- •Patients with venous thrombosis.
- •Patients with active concomitant bleeding of renal origin.
研究组 & 干预措施
Extracapsular fracture with intravenous contraindication (experimental).
Amchafibrin
干预措施: Tranexamic acid (Drug)
Extracapsular fracture with intravenous contraindication (control).
Physiological saline
干预措施: Physiologic saline (Other)
Extracapsular fracture without intravenous contraindication (control).
Physiological saline
干预措施: Physiologic saline (Other)
Extracapsular fracture without intravenous contraindication (experimental).
Amchafibrin
干预措施: Tranexamic acid (Drug)
Intracapsular fracture with intravenous contraindication (control).
Physiological saline
干预措施: Physiologic saline (Other)
Intracapsular fracture with intravenous contraindication (experimental).
Amchafibrin
干预措施: Tranexamic acid (Drug)
Intracapsular fracture without intravenous contraindication (control).
Physiological saline
干预措施: Physiologic saline (Other)
Intracapsular fracture without intravenous contraindication (experimental).
Amchafibrin
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Blood transfusion
时间窗: From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.
Transfusion rate from patient admission to hospital discharge.
次要结局
- Total blood loss(From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.)
- Days at hospital(From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.)
- Adverse events(3,6,9 and 12 months)