Prevention of Postoperative Bleeding in Femoral Fractures: a Multicenter, Randomized, Controlled, Parallel Clinical Trial to Assess the Efficacy of Tranexamic Acid and Fibrin Glue
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 6
- 主要终点
- Blood loss (ml) after surgery
研究概览
简要总结
The main hypothesis of this clinical trial is that the use of intra-articular tranexamic acid and the fibrin glue plus usual hemostasis will reduce at least a 25% the postoperative blood loss with respect to usual hemostasis in patients undergoing subcapital femoral fractures.
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
- None
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
- •Patients over 18 years
- •Patients with unilateral subcapital femoral fracture
- •Patients requiring hip replacement (total or partial)
- •Signed informed consent from the patient or legal representative
排除标准
- •Known allergy to fibrin glue and tranexamic acid
- •Multiple fractures
- •Pathological fractures
- •Contraceptives or estrogen therapy
- •Use of blood salvage during surgery
- •History compatible with thromboembolic disease:
- •Cerebral vascular accident
- •Ischemic heart disease (myocardial infarction, angina )
- •Deep vein thrombosis
- •Pulmonary Embolism
- •Peripheral arterial vasculopathy
- •Patients with thrombogenic arrhythmias
- •Patients with cardiovascular stents
- •Prothrombotic alterations in coagulation
研究组 & 干预措施
Fibrin glue
One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery,
干预措施: Fibrin glue (Drug)
Tranexamic acid
Tranexamic acid, 1g intra-articular before closing the surgery wound
干预措施: Tranexamic Acid (Drug)
Tranexamic acid
Tranexamic acid, 1g intra-articular before closing the surgery wound
干预措施: Electrocauterization (Procedure)
Fibrin glue
One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery,
干预措施: Electrocauterization (Procedure)
Usual hemostasia
Electrocauterization
干预措施: Electrocauterization (Procedure)
结局指标
主要结局
Blood loss (ml) after surgery
时间窗: The first postoperative 24h
The blood lost from the wound will be collected by a drainage system during the first 24 hours postoperatively.
次要结局
- Hidden blood loss(The first postoperative five days)
- Proportion of patients requiring blood transfusion(The first postoperative ten days)
- Units of blood transfused(The first postoperative ten days)
- Proportion of patients with wound infection(The first postoperative month)
- Proportion of patients with wound dehiscence(The first postoperative month)
- Deep venous thrombosis(The first postoperative ten days)
- Length of hospital stay(The first postoperative ten days)
- Quality of life measured with the generic EQ-5D -5L(Preoperatively, at 5 days postoperatively , 1-2, 6 and 12 months postoperative follow-up)
- Mortality(During the 12 month of follow-up after surgery)
- Direct cost(During the first postoperative month)