Effect of Intravenous Tranexamic Acid on Reduction of Blood Losses in Hip Fracture Patients. A Randomized, Controlled, Double-blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- blood transfusion rate
研究概览
简要总结
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 lower extremity fracture care is more limited.
Hip fractures represent a common orthopedic injury in a fragile patient population that often necessitates post-operative blood transfusion thereby putting the patient at additional risk of complications.
The goal of this study is to assess if the use of tranexamic acid in patients with hip fractures will result in a reduction in blood losses and blood transfusion rates.
Our hypothesis is that by providing intravenous TXA at the time of surgery will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for postoperative transfusion.
This a double blinded, placebo controlled, therapeutic trial in which the patients will be randomized to receive TXA or a placebo (saline solution). Treatment will be administered pre-operatively as well as at the time of surgical incision. The primary outcome will be need for blood transfusion. Secondary outcomes will include calculated perioperative blood loss, length of stay, and rate of thromboembolic events, and 90 day mortality.
详细描述
Candidates for the study will be consecutive patients with a diagnosis of hip fractures treated at our center. All patients with hip fracture meeting inclusion criteria will be recruited for enrollment into the study. Informed consent will be obtained from the patient prior to randomization.
At that time, each patient will be randomized into one of two groups by a independent staff using computer generated randomization and allocation concealment. The two patient groups will include:
- Study group: 1g of intravenous tranexamic acid at the time of surgical incision.
- Control group: placebo injection (saline solution) at the time of surgical incision.
Both patients and the treating surgeons will be blinded with regard to placebo vs. treatment until completion of the study.
Patients will be treated surgically with a long trochanteric femoral nail (TFN) or hemiarthroplasty.
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
- Quadruple (Participant, Care Provider, Investigator, 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. Both patients and the treating surgeons will be blinded with regard to placebo vs. treatment until completion of the study
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
- •consecutive patients with a diagnosis of hip fractures treated at our hospital by any surgical procedure
排除标准
- •Age over 60 years
- •Exclusion Criteria:
- •Concomitant fracture
- •Refusal to receive blood products
- •Preoperative anemia needing blood transfusion before surgery
- •Severe comorbidity (cancer, severe pulmonary disease)
- •Allergy for tranexamic acid.
- •History of acute thromboembolic event (Deep Vein Thrombosis, Pulmonary Embolism, Stroke)
- •Coagulopathy (INR > 1.4)
- •Myocardial infarction in the previous 12 months
- •Coronary stents
- •Renal function impairment (serum creatinine > 2 mg/dL or creatinine clearance <30 mL/min),) or kidney transplant
- •Platelet antiaggregant treatment in the week before surgery.
- •Severe hepatic dysfunction (AST/ALT >60)
- •History of hypercoagulability
- •Acquired disturbances of color vision.
- •Occurrence intraoperative surgical/medical/anesthetic complications
研究组 & 干预措施
Control group
Saline solution, 100 mL intravenous at the time of surgical incision
干预措施: Saline Solution (Drug)
TXA group
Tranexamic acid, a single dose of 1 g intravenous diluted in 100 mL saline solution at the time of surgical incision
干预措施: Tranexamic Acid (Drug)
TXA group
Tranexamic acid, a single dose of 1 g intravenous diluted in 100 mL saline solution at the time of surgical incision
干预措施: Saline Solution (Drug)
结局指标
主要结局
blood transfusion rate
时间窗: Hospital stay, from admission to fourth day after surgery
Number of patients needing blood transfusion
次要结局
- Infection rate(90 postoperative days)
- Perioperative Blood Loss(Hospital stay, from admission to fourth day after surgery)
- Thrombotic events(90 postoperative days)
- Mortality(90 postoperative days)
研究者
Alejandro Lizaur-Utrilla, PhD, MD
Head of Orthopaedic Surgery Department
Elda University Hospital