Prophylactic Administration of One Versus Two Doses of Tranexamic Acid in Surgically Treated Patients With Pertrochanteric and Subtrochanteric Femoral Fractures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of allogeneic blood transfusion
研究概览
简要总结
The goal of this clinical trial is to learn whether giving one dose or two doses of tranexamic acid can safely lower blood loss in older adults having surgery for certain hip fractures. The study includes adults aged 65 years or older who need surgery for pertrochanteric or subtrochanteric hip fractures.
The main questions the study aims to answer are:
- Does giving two doses of tranexamic acid lower the need for blood transfusions compared to one dose?
- Does tranexamic acid help keep hemoglobin levels higher after surgery?
- Is tranexamic acid safe in this group of participants? Researchers will compare participants who receive one dose of tranexamic acid with those who receive two doses to see which approach works better and is safe.
Participants will:
- Receive either one dose of tranexamic acid before surgery or two doses, one before and one after surgery
- Have standard surgery to fix their hip fracture within 48 hours of hospital admission
- Be monitored during their hospital stay for blood loss, transfusions, and medical problems
- Be followed for up to 90 days after surgery to check for safety A total of 120 participants will take part in this study, which is being conducted at the University Clinic "St. Naum Ohridski" in Skopje, North Macedonia.
详细描述
This prospective, randomized,single-center clinical study is conducted at the University Clinic for Surgical Diseases "St. Naum Ohridski." Adults aged 65 years or older with pertrochanteric or subtrochanteric femoral fractures are eligible. All patients undergo surgery within 48 hours of admission, according to current recommendations for treatment of pertrochanteric and subtrochanteric fractures. Fractures are classified according to the AO/OTA system by at least two trauma surgeons; discrepancies are resolved by discussion.
Routine preoperative evaluation is performed according to institutional standards and may include patient history, physical examination, standard imaging (X-ray of the pelvis and affected hip, with additional CT scans if indicated), laboratory tests including complete blood count, biochemistry, and coagulation tests, as well as anesthesia assessment. Relevant comorbidities and chronic medications are recorded.
Eligible participants are randomly assigned to one of two treatment groups. One group receives a single prophylactic dose of tranexamic acid, while the other receives two doses according to the study protocol. All participants receive standard surgical and anesthetic care in accordance with institutional practice.
Surgical Procedure:
Surgery is performed under spinal or general anesthesia. Stable pertrochanteric fractures are treated with DHS or short intramedullary nail. Unstable pertrochanteric and subtrochanteric fractures are treated with intramedullary nailing. Reduction may be open or closed, with fluoroscopic guidance. Wound closure is standard; drain placement is at surgeon discretion.
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, Investigator, Outcomes Assessor)
盲法说明
Masking Participants will be randomly assigned to one of two groups using computer-generated random numbers with 1:1 allocation. Allocation results will be sealed in opaque envelopes and opened by the anesthesiology nurse immediately before surgery. The surgical team and patients will be fully blinded. Tranexamic acid and placebo will be prepared in identical syringes (same volume, color, and appearance) so that neither the surgical team nor the patient knows the assigned treatment. One group will receive a single dose of tranexamic acid before incision and placebo three hours later, while the other group will receive two doses of tranexamic acid, before incision and three hours postoperatively.
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
- •Written informed consent obtained
- •Patients aged 65 years or older
- •Patients with pertrochanteric femoral fracture (AO/OTA classification: 31A1.2, 31A1.3, 31A2, 31A3) or subtrochanteric femoral fracture (AO/OTA classification: 32; fractures from the level of the lesser trochanter to 5 cm distally)
- •Surgical treatment performed within 48 hours of hospital admission
排除标准
- •Age younger than 65 years
- •Known allergy or hypersensitivity to tranexamic acid
- •Active thromboembolic event (deep vein thrombosis, arterial thrombosis, pulmonary embolism) or history of vascular event within the past year (myocardial infarction, coronary or peripheral vascular stenting, thromboembolism, stroke)
- •Impaired renal function defined as serum creatinine >120 µmol/L in the last preoperative laboratory test
- •History of malignant disease
- •History of seizure disorder or chronic anticonvulsant therapy
- •Polytrauma or multiple trauma
- •More than one fracture
- •Previous fracture of the same hip
- •Preoperative hemoglobin level <8 g/dL (last laboratory test before surgery)
- •Thrombocytopenia or other coagulation disorders
- •Treatment with vitamin K antagonists with INR >1.5
- •Treatment with low-molecular-weight heparins without appropriate preoperative discontinuation according to clinical protocol (usually ≥24 hours for prophylactic doses and ≥24-36 hours for therapeutic doses)
- •Treatment with direct oral anticoagulants without appropriate preoperative discontinuation (usually 24-48 hours, depending on renal function and bleeding risk)
- •Treatment with P2Y12 inhibitors (e.g., ticagrelor, clopidogrel, prasugrel) when, according to anesthesiologist assessment, surgery cannot be safely performed within 48 hours
研究组 & 干预措施
Group A: Single-Dose TXA
Patients will receive a single intravenous dose of 15 mg/kg Tranexamic Acid 10-20 minutes before the surgical incision, followed by a placebo(saline solution) 3 hours later.
干预措施: Tranexamic acid (Drug)
Group B: Two-Dose TXA
Patients will receive a 15 mg/kg intravenous dose of Tranexamic acid 10-20 minutes before the surgical incision and a second intravenous dose of 15 mg/kg Tranexamic Acid 3 hours after the first dose
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Incidence of allogeneic blood transfusion
时间窗: From start of surgery through postoperative day 5.
Comparison of the incidence of intraoperative and postoperative allogeneic transfusions (≥1 unit of red blood cells) between patients receiving a single intravenous dose of tranexamic acid (15 mg/kg, pre-incision) and those receiving two doses (15 mg/kg pre-incision + 15 mg/kg 3 hours after the first dose).
次要结局
- Hemoglobin drop(Preoperative to postoperative day 3)
- Total and hidden blood loss(From start of surgery through postoperative day 3)
- Volume of transfused blood products(From start of surgery through postoperative day 5.)
- Length of hospital stay(From surgery through hospital discharge up to 30 days postoperatively)
- Incidence of thrombotic events(Up to 90 days postoperatively)
- Mortality(30 and 90 days postoperatively)
- Subgroup analysis by osteosynthesis type(From preoperative baseline up to 90 days postoperatively)
研究者
Angelina Krsteva
MD
University Hospital for Surgical Diseases St. Naum Ohridsk i- Skopje