Use of Combined Tranexamic Acid and Intravenous Iron for Hip Fracture Surgery in Elderly
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- transfusion
研究概览
简要总结
It is a prospective randomized controlled study aiming to test if tranexamic acid combined to intravenous iron before and after surgery for hip fracture in elderly can decrease peri-operative red cell transfusion.
详细描述
Hip fracture is an increasing problem. Anemia is a common finding in these patients with a prevalence ranging from 24% to 44% and is a strong negative prognostic marker. Several studies have explored whether interventions to improve anemia result in better outcomes. Thus, alternatives to allogenic red cell transfusion have been suggested in hip fracture, such as IV iron and tranexamic acid.
The aim of the study is to test the effect of combination of IV iron with tranexamic acid before and after surgery for hip fracture on incidence of peri-operative red cell transfusion.
It is a prospective randomized single-blinded monocentric study including 150 patients undergoing hip fracture surgery within 72 h after trauma aged ≥ 60 years divided in 3 groups: Group A (IV fer+Tranexamic acid), Group B (Tranexamic acid), Group C (placebo). The main outcome was percentage of patients who receive red-cell transfusion during hospitalization. Hemoglobin levels up to 60 days post-operatively and incidence of thrombotic events were secondary outcomes.
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 (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing hip fracture surgery within 72 h after trauma.
排除标准
- •Vascular events within the last 2 months such as cerebrovascular accident (CVA), Myocardial infarction (MI), Venous Thromboembolism (VTE) and/or recurrent VTE or arterial thrombosis.
- •Patients receiving anticoagulation therapy with warfarin or clopidogrel.
- •History of seizures.
- •Multiple fractures.
- •Transfusion received during admission, prior to surgery (Hb< 8g/dl).
- •Creatinine clearance less than 30 mL/min
- •Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
- •Coronary stent placement within the previous 6 months
- •Disseminated intravascular coagulation
- •Subarachnoid hemorrhage
- •Allergy for tranexamic acid
- •Hypersensitivity to Iron sucrose or any component of the formulation
- •Clinical signs of acute thromboembolic event
- •Malignancy
- •Body weight > 100kg
- •Advanced Dementia
研究组 & 干预措施
Tranexamic acid - intravenous iron
IV iron (Ferroven®) : 2 vials of 10 mL containing each one 100 mg iron, diluted in 100 mL normal saline over 30 minutes before induction of anesthesia and repeated on day two and three.
IV Tranexamic acid (Exacyl®): 1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later.
干预措施: tranexamic acid (Exacyl®) (Drug)
Tranexamic acid - intravenous iron
IV iron (Ferroven®) : 2 vials of 10 mL containing each one 100 mg iron, diluted in 100 mL normal saline over 30 minutes before induction of anesthesia and repeated on day two and three.
IV Tranexamic acid (Exacyl®): 1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later.
干预措施: intravenous iron (Ferroven®) (Drug)
Tranexamic acid
IV Tranexamic acid (Exacyl®): 1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later.
干预措施: tranexamic acid (Exacyl®) (Drug)
Placebo
20 mL saline, in 30 minutes, five minutes before skin incision and 20 ml 3 hours later.
干预措施: Saline (Other)
结局指标
主要结局
transfusion
时间窗: 5 days
percentage of patients who receive red-cell transfusion during hospitalization
次要结局
- Average red-cell packs per patient(5 days)
- blood loss(5 days)
- haemoglobin level(day 60)
- Thromboembolic events(day 60)
- Post-operative bacterial infection(day 60)
- number of days in hospital(day 10)
- Functional mobility(day 60)
- mortality(day 60)