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临床试验/NCT05359172
NCT05359172已完成不适用

Does Tranexamic Acid Significantly Reduce Total Blood Loss During Proximal Femoral Nailing for the Intertrochanteric Femoral Fracture in the Elderly?

Haseki Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Total blood loss

研究概览

简要总结

Blood loss is an important issue following intertrochanteric femoral fracture and may lead to requiring blood transfusions and transfusion complications. Tranexamic acid is a commonly used drug to decrease blood loss and the number of transfusions. The aim of our study is to determine the effectiveness of tranexamic acid use to reduce total blood loss during proximal femoral nailing for the intertrochanteric femoral fracture in the elderly.

Patients aged >65 years and diagnosed with intertrochanteric fracture will be included in the study. The patients will be numbered according to the admission to the hospital and randomly divided into two groups. First group will receive tranexamic acid infusion and second group will not receive tranexamic acid infusion. Total blood loss will be calculated using Nadler formula. The primary outcome of the study is total blood loss. The secondary outcomes are a number of transfusions, and surgical blood loss during the operative procedure.

详细描述

Introduction Intertrochanteric femur fractures may cause an average of 800-1500 cc of bleeding. Hip fractures, which reduce the intravascular volume so much, can cause serious metabolic problems in the elderly patient population. There may also be some blood loss during the operation, and these blood losses can cause decreased mobility, overload of the cardiovascular system, deterioration of tissue oxygenation, increased mortality and morbidity. In addition, it may require blood transfusion and cause possible tranfusion complications.

The aim of our study is to determine the effectiveness of tranexamic acid use to reduce total blood loss during proximal femoral nailing for the intertrochanteric femoral fracture in the elderly.

Material and method Patients diagnosed with intertrochanteric fractures admitted to the emergency department between April 1, 2020 and April 30, 2022 were eligible for this study. Inclusion criteria were (1) Patients aged ≥ 65 years with intertrochanteric fracture (2) treated with closed reduction and proximal femoral nailing (3) injury time ≤ 8 h. Exclusion criteria were having undergone previous surgery on the same hip, fracture requiring open reduction, having any contraindications for the use of tranexamic acid (allergy, previous thromboembolic event, creatinine clearance <30 ml/min, postmenopausal hormonal therapy), patients with recent or ongoing thromboembolic events (deep venous thrombosis, pulmonary embolism, arterial thrombosis, or cerebral thrombosis stroke); patients who were recently taking or who were taking anticoagulation therapy including vitamin K-antagonists, direct thrombin inhibitors, direct factor X-a inhibitors, and platelet aggregation inhibitors; patients with disseminated intravascular coagulation or patients had hepatic or renal diseases with impairment of coagulation function.

When patients apply to our hospital, they will be numbered according to the order of application. It will then be randomized using the www.randomizer.org website. In Group 1, 15 mg/kg tranexamic acid will be administered before the incision, after anesthesia in the form of iv infusion in 100 cc saline. In Group 2, only 100 SF will be applied. During surgery, crystalloid fluids will be administered at a dose of 1.5 ml/kg.h. In case of blood loss; Intravascular volume will be maintained with 3:1 ratio of crystalloid solutions. A change in basal heart rate and blood pressure of more than 20% is considered to be related to hypovolemia and will be replaced with a 10ml/kg bolus of crystalloid solution. Perop blood transfusion will be administered in case of Hb<8 g/dl or suspected myocardial ischemia or hemorrhagic shock. In case of Hb<8 g/dl or Hb<10g/dl and symptoms of hypovolemia (dizziness, orthostatic hypotension, tachycardia), blood transfusion indication will be accepted in the postoperative period.

Electrocautery and aspirator will be routinely used during the surgical procedure in all patients. Preoperative DVT prophylaxis will be applied to the patients and antiembolic stockings will be worn. After the operation of the patient, the total amount of perop bleeding will be determined by removing the irrigation fluids from the total amount of liquid in the aspiration material and the blood on gauzes used in the operation will be added. If there is a drain in the postoperative period, the drainage volume will be added. Nadler's formulae for blood volüme, visible and hidden blood loss were applied after surgery.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged ≥ 65 years with intertrochanteric fracture
  • Treated with closed reduction and proximal femoral nailing
  • Injury time ≤ 8 h.

排除标准

  • Having undergone previous surgery on the same hip,
  • Fracture requiring open reduction,
  • Having any contraindications for the use of tranexamic acid
  • Patients with recent or ongoing thromboembolic events
  • Patients who were recently taking or who were taking anticoagulation therapy and platelet aggregation inhibitors;
  • Patients with disseminated intravascular coagulation or patients had hepatic or renal diseases with impairment of coagulation function.

研究组 & 干预措施

Tranexamic acid

They will receive preoperative intravenous tranexamic acid infusions.

干预措施: Tranexamic acid (Drug)

结局指标

主要结局

Total blood loss

时间窗: 2 days

Estimated total blood loss (L) =Blood volume × (Hctpreop -Hctpostop) /\[(Hctpreop +Hctpostop)/2\]

次要结局

  • number of transfusions(postroperative first month)

研究者

发起方
Haseki Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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